Multiple-firing suture fixation device and methods for using and manufacturing same

ABSTRACT

A multiple-firing clip device comprises a shaft comprising an exterior surface, an interior receiving therein suture fixation clips, and a distal end opening shaped to eject a suture fixation clip therefrom. The shaft defines a lateral opening and a distal shaft portion between the lateral opening and the distal end opening. A shuttle moves on the shaft and comprises a shuttle body, a snare having a distal snare portion, and a snare extension slide movable from the shuttle body along a given extent defining a slide distance and a distal end. The shuttle extends at least the distal snare portion distally through the lateral opening from the environment into the interior, through the distal shaft portion, and through the distal end opening along a length that is at least equal to the slide distance when the snare extension slide moves to the distal end of the given extent.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/254,369, filed on Sep. 1, 2016, now U.S. Pat. No. 10,327,759, whichis a continuation of U.S. patent application Ser. No. 14/543,240, filedon Nov. 17, 2014, now Pat. No. 10,016,193, issued Jul. 10, 2018, whichclaims the benefit of U.S. patent application Ser. Nos. 61/905,578,filed Nov. 18, 2013; 61/951,162, filed Mar. 11, 2014; and 62/069,183,filed Oct. 27, 2014, all of the prior applications incorporated hereinin their entireties.

FIELD OF THE INVENTION

The present invention lies in the field of securing cords, such assurgical sutures. The present disclosure relates to a multiple-firingsuture fixation device and methods for using and manufacturing same.

BACKGROUND OF THE INVENTION

Surgical instruments, such as the Cor-Knot manufactured by LSI Solutionsand as described in U.S. Pat. No. 7,833,237 to Sauer, are used toreplace hand tied knots at remotes sites within the body. Suchinstruments, however, are limited to use with a single suture and asingle crimp and generate significant waste during the suture tyingprocess, which waste must be accounted for and could be lost within thepatient during surgery if safeguards are not taken. In this system, asingle suture crimp is loaded into the end effector and is secured for asingle crimp use. To load the crimp and the snare that passes the suturethrough the crimp, a loading hook is passed through an end effector. Theloading hook has the crimp at its distal end and is attached to a snareloop, which is threaded through the crimp. To secure the crimp betweenthe handle and the snare loop, the snare loop is secured and heldoutwards as a loop by a teardrop shaped plastic handle. After the hookis threaded into the end effector and the crimp is pressed into thedistal end of the end effector, the user must remove the large, plastichandle and dispose of it properly. As such, the action of loading areload crimp into the device generates a teardrop shaped piece ofplastic waste for every single crimp. Care must be taken because thereis no positive method of securing the crimp into the ready positionwithin the crimping device. If the crimp becomes dislodged, it may notform a proper securing crimp. This may require the suture to bereplaced, which may be extremely difficult. Once the snare loop is usedto pull the sutures through the crimp, the snare loop must also bediscarded. If during the process of passing the sutures through thecrimp the sutures do not fully pass through the crimp, it is possiblethat the very small crimp could be dislodged from the crimping deviceand potentially lost within the patient.

It would be beneficial to provide a cord-loading device that has minimalor no waste generated during a procedure and that provides multiplecrimps that do not need to be individually loaded during the procedure.

SUMMARY OF THE INVENTION

A multiple-firing suture fixation device and methods for using andmanufacturing same that overcome the hereinafore-mentioned disadvantagesof the heretofore-known devices and methods of this general type aredescribed and shown herein.

The multiple-firing crimp device does not generate waste during aprocedure and allows enough crimps for a complete procedure to be loadedbefore the procedure and, therefore, do not need to be individuallyloaded during the procedure. The multiple-firing crimp device holds anumber of crimps within the device prior to performing a procedure.During the procedure, the multiple-firing crimp device automaticallyloads a single crimp in a crimp-delivery position that is ready to becrimped and is in a position allowing cords to pass therethrough forcrimping after the cords are tightened. The multiple-firing crimp deviceprovides a mechanism that passes the cords through one crimp, placingthe crimp in a read-to-fire position. The multiple-firing crimp deviceprovides a reliable, reusable way of passing the cords through one crimpat a time for each of the multiple loaded crimps. There is no waste orseparate parts to account for during or after a surgical procedure.

As used herein, the multiple-firing crimp device is able to be used oncords. As defined herein, the term cords is not limited to a pluralityof cords, cords can be a single cord as well. For example, four lengthsof cord can be threaded through a crimp for securing one or more of thecords therein after crimping occurs. Cords also are not limited to aparticular type of material. The material can be made of natural fibers,man-made or synthetic fibers, plastics, and/or metals, to name a few.Cords also are not limited to a particular structure. The material canbe made of twisted strands, twisted strands with a central core, or asingle strand or wire, to name a few. One exemplary embodiment describedherein relates to securing a surgical suture with a crimp of themultiple-firing crimp device. The embodiments described herein, however,are not limited to surgical sutures, even though the example of surgicalsutures is referred to or is used herein.

Traditionally, surgical sutures are cut by advancing a movable knife.One exemplary embodiment of the multiple-firing crimp device uses amovable knife. Another exemplary embodiment of the multiple-firing crimpdevice, instead, uses a fixed knife and a blunt pusher that contacts thesuture and moves it to and against the fixed knife for cutting. Thisconfiguration prevents cutting from happening prematurely and allowsprecise control of the distance that the suture is cut from the crimp.

If a snare is damaged during a procedure, the entirety of shuttlecontaining the snare can be removed from the handle and the shaft and anentirely new shuttle from a separate, sterilized package can be used inplace of the damaged shuttle.

In general, the systems and methods herein provide ways to pull cordssuch as surgical sutures through a set of cord clips. In any multi-fireclip/crimp applier device for fixing cords, a user must be able to pullthe cords through a single clip where multiple clips are loaded in thedevice. In other words, the device must be a reusable clip-threadingdevice. The mechanism that pulls through the clip must be easy to use,have a low profile, and, significantly, should not be able to leavebehind any separate parts and should not produce waste during use. Thechallenges associated with such a device arise because the device musthave a low profile in general and also must be able to thread cordsthrough a very small diameter clip (e.g., crimp).

Many steps are undertaken in order to crimp a clip onto cords with amulti-fire crimp applier. First, the clip must be loaded from a magazineof multiple clips. Then, the cords must be threaded through that oneclip that is to secure the cords but not be threaded within or interferewith the other clips in the magazine. Then, the clip must be secured(e.g., crimped) onto the cords at a location that is, typically, veryclose to a cord-tying location (e.g., a surgical site). Finally, thedevice must be able to cut the cords after the clip, dispose of the cutends, and present a new clip for use next with as little usermanipulation as possible.

It is beneficial to provide an automated device. In such a device, thereare different moving assemblies, such as a clip carriage, asnare-extender, a cord lifter, a crimper, and a cutter. A handlecontains automated motors, servos, and/or transmissions to carry out thefunctions of each of these movement assemblies. The handle is providedwith a single mechanical control device for each of these assemblies orcombination control devices that effect two or more functions.Alternatively some or all of the automated actions can be replaced withmechanical systems. In any embodiment, simplicity in the entire processof installing a new clip, securing the clip at the cords, and loadinganother clip for repetitive cycles is important. One exemplaryembodiment provides a shuttle that translates on the shaft of the deviceand, when positioned distally, presents a loop into which the cords tobe secured are passed. The loop is, then, pulled back into the shuttlebefore the shuttle begins to move proximally. The proximal motion of theshuttle utilizes the loop to draw the cords through the crimp and exposethem to the outside of the shaft. The shuttle has a formed wire guide orchannel that resides outside of the outer diameter of the device's shaftand through a window in a side of the shaft (e.g., at an upper side) andthat wire guide is able to move from outside the shaft to inside theshaft and, then, into or through a proximal end of the crimp. When thetails of cords are pulled through the crimp with the shuttle, the tailsare dropped off external to the shaft so that they can be grabbed by theuser's hands for tensioning and subsequent crimping.

The shuttle contains various interlocks. One interlock prevents theformed wire snare from being presented until the shuttle is in adistal-most position. Another interlock prevents the shuttle from movingproximally if the snare is extended in any way. Another interlock holdsthe shuttle at a distal-most position for (1) extending the snare and(2) retracting the cords with movement of a shuttle saddle to positionthe cords in a radiused tip of the snare. Another interlock prevents thesnare from moving when the cords reside in the tip and the shuttle ismoving proximally to pass the cords through the crimp and thereafterpresent the cords outside the shaft for handling by the user.

An exemplary embodiment of the snare is formed and created from Nitinoland has a tight-radiused tip section that prevents the snare frompinching on the cords it snares while it pulls the cords through thecrimp and then moves the cords to the outside of the shaft. Thistight-radiused tip also ensures entry into a snare guide tube. Thereservoir tip of the snare is stopped short of coming into the shuttleto form an open loop that allows the free tails of the cords to beexposed after passing through the crimp and falling free outside theshaft. The snare may be formed of any number of materials such asstainless steel, titanium, or a polymer.

Ideally, when the handle is in the middle of any of the crimping,cutting, or loading processes, the handle prevents the shuttle frommoving away from the nose of the handle. In contrast, when the shuttleis advanced away from the handle, handle functions may be enabled ordisabled as appropriate when the shuttle is either moving or is awayfrom the nose.

Additional interlocks are present to enable/lock out functions in thehandle based on a position of the shuttle when in its most proximalposition, e.g., resting against the handle. After the shuttle is at thenose of the handle, the user can pull on the cords that run through thecrimp and hang loose through a window of the shaft. When in the snaringposition, the shuttle can be held by friction and/or with one or moredetents.

With the foregoing and other objects in view, there is provided, amultiple-firing crimp device comprises crimps, a hollow shaft, a crimpmovement assembly, and a snare. Each crimp has an internal hollow. Theshaft has a distal crimping location, an exterior surface, and aninterior in which is stacked the plurality of crimps to define a firstcrimp, the crimps moving therein along a longitudinal axis. The shaftdefines a lateral opening proximal to the crimping location andcommunicates between the interior and the environment outside theexterior surface. The crimp movement assembly within the interior of theshaft delivers the first crimp to the distal crimping location by movingthe first crimp longitudinally from a first proximal position into thedistal crimping location and returning to a second proximal positionwithout the first crimp. The snare pulls at least one cord from distalof the first crimp through the first crimp and through a portion of theshaft and out the side of the shaft through the lateral opening.

With the objects in view, there is also provided a multiple-firing crimpdevice comprises crimps, a hollow shaft, a crimp movement assembly, asnare, and a snare movement assembly. Each crimp has an internal hollow.The shaft has a distal crimping location, an exterior surface, and aninterior in which is stacked the plurality of crimps to define a firstcrimp, the crimps moving therein along a longitudinal axis. The shaftdefines a lateral opening proximal to the crimping location andcommunicating between the interior and the environment outside theexterior surface. The crimp movement assembly within the interior of theshaft delivers the first crimp to the distal crimping location by movingthe first crimp longitudinally from a first proximal position into thedistal crimping location and returning to a second proximal positionwithout the first crimp. The snare pulls at least one cord from distalof the first crimp through the first crimp and through a portion of theshaft and out the side of the shaft through the lateral opening. Thesnare movement assembly includes the snare. The snare is shaped to passthrough the internal hollow of the first crimp, to pass out of theinterior of the shaft distally past the distal crimping location, and tosecure the at least one cord temporarily. The snare movement assemblymoves the snare to pull a portion of the at least one cord secured inthe snare proximally through the first crimp and to present at leastsome of the portion of the at least one cord out through the opening foraccess by a user.

In accordance with another feature, there is provided a snare movementassembly having the snare. The snare is shaped to pass through theinternal hollow of the first crimp, to pass out of the interior of theshaft distally past the distal crimping location, and to secure the atleast one cord temporarily. The snare movement assembly moves the snareto pull a portion of the at least one cord secured in the snareproximally through the first crimp and to present at least some of theportion of the at least one cord out through the opening for access by auser.

In accordance with a further feature, there is provided a crimpingassembly having a crimp control device that, when actuated, crimps thefirst crimp within the distal crimping location and a cutting assemblyhaving a cutting control device that, when actuated, cuts the portion ofthe at least one cord adjacent the first crimp.

In accordance with an added feature, the at least one cord is a surgicalsuture.

In accordance with an additional feature, the portion of the at leastone cord secured in the snare is two free ends of a surgical suture, theend opposing the two free ends being a loop of the surgical suturesecured in a surgical site, the portion of the at least one cord securedin the snare and being pulled proximally through the first crimp is thetwo free ends such that, at a given time, four lengths of the surgicalsuture are being pulled through the first crimp, and the at least someof the portion of the at least one cord pulled out through the openingfor access by a user is the two free ends of the surgical suture.

In accordance with yet another feature, the first crimp is a distal-mostone of the crimps.

In accordance with yet a further feature, the internal hollow is one ofa lumen and a slot.

In accordance with yet an added feature, the crimps are crimp sleeveshaving a hollow through bore, at least a portion of the bore beinginternally threaded.

In accordance with yet an additional feature, the first proximalposition is different from the second proximal position.

In accordance with again another feature, the first proximal position isthe same as the second proximal position.

In accordance with again a further feature, when the crimp movementassembly returns to the second proximal position, the lateral opening isexposed to the environment outside the exterior surface.

In accordance with again an added feature, while or after the crimpmovement assembly is in the process of returning to the second proximalposition without the first crimp, the crimp movement assembly moves apreviously second of the crimps into a crimp loading position to becomea new first crimp.

In accordance with again an additional feature, the shaft has a distalcam driver and the crimp movement assembly comprises anexterior-threaded carriage movably disposed inside the shaft along thelongitudinal axis towards and away from the distal cam driver and havinga carriage distal end at which is disposed the first crimp.

In accordance with still another feature, each of the crimps has aninterior thread and is threaded on the exterior threads of the carriageat a spacing from one another such that rotation of the carriage in adirection selectively carries a distal-most one of the crimps off thecarriage distal end.

In accordance with still a further feature, there is provided a hammermovably disposed inside the shaft adjacent the distal cam driver andhaving a cam follower operatively connected to the distal cam driver tomove the hammer towards and away from the longitudinal axis of the shaftwhen the shaft is moved along the longitudinal axis, an anvil at leastpartially disposed inside the shaft adjacent the distal cam driver andopposite the hammer, and the distal crimping location is between thehammer and the anvil.

In accordance with still an added feature, the snare is shaped to extendthrough the interior of the carriage and pass through the internalhollow of the first crimp.

In accordance with still an additional feature, the first crimp has aproximal end and which further comprises a user-movable snare movementassembly having the snare, a hollow snare guide in which is disposed thesnare, the snare guide being disposed external to the shaft and, whenmoved distally, moving through the lateral opening and up to theproximal end of the first crimp, and a snare extension device moving thesnare distally through the snare guide, through the first crimp, andpast the distal crimping location of the shaft to secure the at leastone cord temporarily and pull at least a portion of the at least onecord through the first crimp and out the lateral opening.

In accordance with another feature, the first crimp has a proximal endand which further comprises movable snare movement assembly having acord lifter within the shaft, adjacent the snare, and shaped to lift atleast one of the snare and the at least one cord and a snare extensiondevice moving the snare distally along the cord lifter, through thefirst crimp, and past the distal crimping location of the shaft tosecure the at least one cord temporarily and pull at least a portion ofthe at least one cord through the first crimp and past the cord lifter,the cord lifter, when actuated, presenting at least some of the portionof the at least one cord out the lateral opening for access by a user.

In accordance with another feature, there is provided a cutting assemblyhaving a cutter within the shaft extending parallel to the longitudinalaxis and shaped to cut the at least one cord adjacent the first crimpand a cutter control device connecting the cutter to the shaft to havethe cutter move and cut the at least one cord adjacent the first crimpwhen the shaft is at a distal position with respect to one of the hammerand the anvil.

Although the devices and methods are illustrated and described herein asembodied in a multiple-firing suture fixation device and methods forusing and manufacturing same, it is, nevertheless, not intended to belimited to the details shown because various modifications andstructural changes may be made therein without departing from the spiritthereof and within the scope and range of equivalents of the claims.Additionally, well-known elements of exemplary embodiments will not bedescribed in detail or will be omitted so as not to obscure the relevantdetails.

Additional advantages and other features characteristic of the presentdevices and methods will be set forth in the detailed description thatfollows and may be apparent from the detailed description or may belearned by practice of exemplary embodiments. Still other advantages maybe realized by any of the instrumentalities, methods, or combinationsparticularly pointed out in the claims.

Other features that are considered as characteristic for the devices andmethods are set forth in the appended claims. As required, detailedembodiments are disclosed herein; however, it is to be understood thatthe disclosed embodiments are merely exemplary, which can be embodied invarious forms. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as abasis for the claims and as a representative basis for teaching one ofordinary skill in the art to variously employ the present devices andmethods in virtually any appropriately detailed structure. Further, theterms and phrases used herein are not intended to be limiting; butrather, to provide an understandable description thereof. While thespecification concludes with claims defining the features that areregarded as novel, it is believed that the devices and methods will bebetter understood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, where like reference numerals refer toidentical or functionally similar elements throughout the separateviews, which are not true to scale, and which, together with thedetailed description below, are incorporated in and form part of thespecification, serve to illustrate further various embodiments and toexplain various principles and advantages all in accordance with thepresent devices and methods. Advantages of embodiments will be apparentfrom the following detailed description of the exemplary embodimentsthereof, which description should be considered in conjunction with theaccompanying drawings in which:

FIG. 1 is a fragmentary, longitudinal, cross-sectional view of anexemplary embodiment of an end effector for a multiple-firing crimpdevice with a crimp sub-assembly in a position ready to load a firstcrimp;

FIG. 2 is a fragmentary, longitudinal, cross-sectional view of the endeffector of the multiple-firing crimp device of FIG. 1 with the crimpsub-assembly removed;

FIG. 3 is a fragmentary, side elevational and partially longitudinalcross-sectional view of an exemplary embodiment of a portion of a handlefor operating the end effector of FIG. 2 with the crimp sub-assemblyfully retracted;

FIG. 4 is a fragmentary, longitudinal, cross-sectional view of the endeffector of FIG. 1 with the crimp sub-assembly in an extended positionprior to seating of a crimp;

FIG. 5 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle portion of FIG. 3 with the crimpsub-assembly actuators in a carriage-extended position corresponding toFIG. 4;

FIG. 6 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 1 with the crimp sub-assembly in a crimp-seatedposition ready for use;

FIG. 6A is a fragmentary, longitudinally cross-sectional view of anenlarged distal portion of the end effector of FIG. 6;

FIG. 7 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle portion of FIG. 3 with the crimpsub-assembly actuators in a suture-use position corresponding to FIG. 6;

FIG. 8 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 6 with a snare in an extended snare position ready forcapturing one or more cords;

FIG. 9 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle portion of FIG. 3 with the snaresub-assembly actuator in a snare-use position corresponding to FIG. 8;

FIG. 10 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 8 with a snare in an extended snare position ready foror capturing a suture and with the suture screw carriage disengaged fromthe distal-most clip and fully retracted;

FIG. 11 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle portion of FIG. 3 with the snaresub-assembly actuator in a snare-use position corresponding to FIG. 10and with the suture screw carriage disengaged from the distal-most crimpand fully retracted;

FIG. 12 is a fragmentary, perspective view of the end effector of FIGS.8 and/or 10 with cords to be captured extended within the loop of thesnare;

FIG. 13 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 10 enlarged with respect to FIG. 10, with the snare ina partially retracted snare position after capturing cords and with thecords having passed partially through the crimp;

FIG. 14 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 13 reduced with respect to FIG. 13 and with the snarein a further partially retracted snare position after capturing thecords;

FIG. 15 is a fragmentary, side elevational view of the end effector ofFIG. 14;

FIG. 16 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle of FIG. 11 with the snaresub-assembly actuator further retracted than the position of the snarecorresponding to FIG. 12;

FIG. 17 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIGS. 14 and 15 with a cord-lifting device in a loweredposition;

FIG. 18 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 17 with the cord-lifting device in a lifted positionpositioning the cords for grasping by a user;

FIG. 19 is a fragmentary, perspective view of the end effector of FIG.18;

FIG. 20 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle of FIG. 16 with the cord-liftingdevice actuated to position the cord lifter to the positioncorresponding to FIGS. 18 and 19;

FIG. 21 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 19 with the cord-lifting device in a lifted position,with the suture grasped by a user, and with the snare in the partiallyretracted position;

FIG. 22 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 21 with the cord-lifting device in a lowered position,with the cords grasped by a user at an acute angle with the longitudinalaxis of the end effector, and with the snare in a retracted position;

FIG. 23 is a fragmentary, perspective view of the end effector of FIG.22;

FIG. 24 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle of FIG. 20 with the cord-liftingdevice returned to the unactuated position that places the cord-liftingdevice in the lowered position corresponding to FIGS. 22 and 23 and withthe snare actuator in the retracted position;

FIG. 25 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 23 enlarged with respect to FIG. 23 and with the outertube partially extended to move the hammer radially inwards and therebycrimp the crimp to the cords therewithin;

FIG. 26 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle of FIG. 24 with the outer tubeextended distally into the position corresponding to FIG. 25;

FIG. 27 is fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 25 with the crimp and cords removed;

FIG. 28 is fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 25 with the cutter actuator fully extended to move thecutting blade and thereby cut the cords;

FIG. 29 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle of FIG. 26 with the cutter actuatorfully extended distally into the position corresponding to FIG. 28 tothereby cut the captured cords;

FIG. 30 is a fragmentary, perspective view of the end effector of FIG.25;

FIG. 31 is a fragmentary, side elevational and partially longitudinalcross-sectional view of the handle of FIG. 29 with the cutter andcrimping actuators retracted proximally to release the crimped crimp andwith the crimp sub-assembly ready to reload a new crimp into the endeffector;

FIG. 32 is an enlarged perspective view of the crimp of FIG. 1;

FIG. 33 is a longitudinal cross-sectional view of the crimp of FIG. 1;

FIG. 34 is an enlarged perspective view of the crimp of FIGS. 33 and 34after being crimped;

FIG. 35 is an enlarged perspective and longitudinal cross-sectional viewof the crimp of FIGS. 32 and 33 after being crimped;

FIG. 36 is an exemplary embodiment of a distal end of a snare with aloop and its tip expanded;

FIG. 37 is an exemplary embodiment of a snare with a loop and its tipexpanded;

FIG. 38 is another exemplary embodiment of a distal end of a snare witha loop and its tip expanded;

FIG. 39 is a fragmentary, longitudinally cross-sectional view of anexemplary embodiment of an alternative end effector to the device shownin FIGS. 1 to 31 and similar to FIG. 8, wherein the snare is replacedwith a distal hook that hooks the cords and draws them into the assemblyfor securing with a loaded crimp, this embodiment allowing the user tothread the crimp with a single hand that is holding the device's handle;

FIG. 40 is a fragmentary, enlarged perspective view of the end effectorof FIG. 39;

FIG. 41 is a fragmentary, enlarged perspective view of the end effectorof FIG. 40 with the hook holding two leads of a suture;

FIG. 42 is a fragmentary, longitudinally cross-sectional view of anexemplary embodiment of a multiple-firing crimp device having an endeffector with a manually actuated crimp sub-assembly in a position witha first crimp loaded for use;

FIG. 43 is a fragmentary, longitudinally cross-sectional view of themultiple-firing crimp device of FIG. 42 with the manually actuated crimpsub-assembly in a partial snare-movement position toward the firstcrimp;

FIG. 44 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 42;

FIG. 45 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 43;

FIG. 46 is a fragmentary, longitudinally cross-sectional view of themultiple-firing crimp device of FIG. 42 with the manually actuated crimpsub-assembly lowering the snare guide tube into the snare guide tubeloading track and axially aligning with the center of the first crimp;

FIG. 47 is a fragmentary, longitudinally cross-sectional view of themultiple-firing crimp device of FIG. 42 with the manually actuated crimpsub-assembly inserting the snare guide tube up to the center of thefirst crimp for receiving therein the snare, the lowering of the snareguide tube unlocking the snare shuttle for distal movement;

FIG. 48 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 46;

FIG. 49 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 47;

FIG. 50 is a fragmentary, enlarged, partially longitudinallycross-sectional view of the multiple-firing crimp device of FIG. 47;

FIG. 51 is a fragmentary, longitudinally cross-sectional view of themultiple-firing crimp device of FIG. 42 with the manually actuated crimpsub-assembly extending the snare through the snare guide tube andthrough and out from the first crimp for receiving therein the cords tobe snared, movement of the outer body being locked and only permittingmovement of the snare shuttle for snare movement;

FIG. 52 is a fragmentary, longitudinally cross-sectional view of themultiple-firing crimp device of FIG. 51 with cords in the snare;

FIG. 53 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 51;

FIG. 54 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 52;

FIG. 55 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 42 with the manuallyactuated crimp sub-assembly having retracted the snare and the cordsalong with the snare guide tube out from the distal end of the shaftassembly and having pulled the cords through the first crimp, movementof the outer body being free in the proximal direction and movement ofthe snare shuttle being free to retract the snared cords;

FIG. 56 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 42 with the manuallyactuated crimp sub-assembly having completely retracted the snare fromthe cords to allow a user to manually pull the free ends of thepreviously snared suture tight and to place the crimp adjacent to theloop of the cords where crimping is to take place after the user pullstightly on the cords to place the distal end of the device at thecord-tying location;

FIG. 57 is a fragmentary, perspective view of an exemplary embodiment ofa shuttle for the multiple-firing crimp device of FIG. 42

FIG. 58 is a fragmentary, perspective view of an exemplary embodiment ofa multiple-firing crimp device having an end effector with a manuallyactuated crimp sub-assembly in a position with a first crimp loaded foruse, with a shuttle in a ready to use state, and with a handle removed;

FIG. 59 is a fragmentary, perspective view of the multiple-firing crimpdevice of FIG. 58 with the manually actuated crimp sub-assembly with theshuttle in a snare-movement position;

FIG. 60 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 58 with the shuttle in anintermediate position between the handle and the crimp and with a snarescroll removed;

FIG. 61 is a fragmentary, enlarged, partially transparent,longitudinally cross-sectional view of the multiple-firing crimp deviceof FIG. 58 with the shuttle in an intermediate position between thehandle and the crimp and with the snare scroll removed;

FIG. 62 is a fragmentary, enlarged, transparent, longitudinallycross-sectional view of the multiple-firing crimp device of FIG. 58 withthe shuttle in an intermediate position between the handle and the crimpand with the snare scroll removed;

FIG. 63 is a fragmentary, enlarged, partially transparent,longitudinally cross-sectional view of the multiple-firing crimp deviceof FIG. 59 with the shuttle in a snare-movement position;

FIG. 64 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 59 with the shuttle in thesnare-movement position;

FIG. 65 is a fragmentary, enlarged, transparent, longitudinallycross-sectional view of the multiple-firing crimp device of FIG. 59 withthe shuttle in the snare-movement position;

FIG. 66 is a fragmentary, perspective view of the multiple-firing crimpdevice of FIG. 58 with the manually actuated crimp sub-assembly with theshuttle in a snare-extended position;

FIG. 67 is a fragmentary, enlarged, partially transparent,longitudinally cross-sectional view of the multiple-firing crimp deviceof FIG. 66 with the shuttle in the snare-extended position;

FIG. 68 is a fragmentary, enlarged, longitudinally cross-sectional viewof the multiple-firing crimp device of FIG. 66 with the shuttle in thesnare-extended position;

FIG. 69 is a fragmentary, enlarged, transparent, longitudinallycross-sectional view of the multiple-firing crimp device of FIG. 66 withthe shuttle in the snare-extended position;

FIG. 70 is a fragmentary, perspective view of an exemplary embodiment ofa distal end of a multiple-firing crimp device having a distal headlightassembly in an off state and an end effector with a manually actuatedcrimp sub-assembly in a position with a first crimp loaded for use andwith a shuttle in a ready to use state;

FIG. 71 is a fragmentary, partially transparent, perspective view of themultiple-firing crimp device of FIG. 70;

FIG. 72 is a fragmentary, perspective view of the multiple-firing crimpdevice of FIG. 70 with a headlight cover removed;

FIG. 73 is a fragmentary, transparent, perspective view of themultiple-firing crimp device of FIG. 70;

FIG. 74 is a fragmentary, partially transparent, perspective view of themultiple-firing crimp device of FIG. 70 with the shuttle in thesnare-extended position;

FIG. 75 is a perspective view of a left side of an alternative exemplaryembodiment of a shuttle body;

FIG. 75A is a transparent, perspective view of the shuttle body of FIG.75;

FIG. 75B is a perspective view of a right side of the shuttle body ofFIG. 75;

FIG. 76 is a perspective view of a left side of an alternative exemplaryembodiment of a shuttle body with snare-extender slide removed;

FIG. 76A is a transparent, perspective view of the shuttle body of FIG.76;

FIG. 76B is a perspective view of a right side of the shuttle body ofFIG. 76;

FIG. 77 is a perspective view of a left side of a left half of analternative exemplary embodiment of a shuttle body with snare-extenderslide removed;

FIG. 77A is a transparent, perspective view of the shuttle body half ofFIG. 77;

FIG. 77B is a perspective view of a right side of the shuttle body halfof FIG. 77;

FIG. 78 is a perspective view of a left side of an alternative exemplaryembodiment of a shuttle body with snare-extender slide removed;

FIG. 78A is a transparent, perspective view of the shuttle body of FIG.78;

FIG. 78B is a perspective view of a right side of the shuttle body ofFIG. 78;

FIG. 79 is a fragmentary, perspective view of a right side of anexemplary embodiment of a handle for a multiple-firing crimp device withthe right half of the handle body removed;

FIG. 80 is a fragmentary, perspective view of the handle of FIG. 79 witha cover of a carriage movement assembly transparent;

FIG. 81 is a fragmentary, side elevational view of a right side of thehandle of FIG. 79 in a crimp-retracted state;

FIG. 82 is a fragmentary, side elevational view of the right side of thehandle of FIG. 79 in a crimp-holding state;

FIG. 83 is a fragmentary, side elevational view of the right side of thehandle of FIG. 79 in a clutched state;

FIG. 84 is a fragmentary, side elevational view of the right side of thehandle of FIG. 79 in a crimp-extended state;

FIG. 85 is a fragmentary, perspective view of an exemplary embodiment ofan end effector of a multiple-firing crimp device with a fixed blade anda blade pushrod in a fully retracted position and a crimping assembly ina non-crimping state;

FIG. 86 is a fragmentary, perspective view of the end effector of FIG.85 with the outer tube transparent;

FIG. 87 is a fragmentary, perspective view of the end effector of FIG.86 with the crimping assembly in a crimped state;

FIG. 88 is a fragmentary, perspective view of the end effector of FIG.87 with the blade pushrod in a partially actuated state before cutting;

FIG. 89 is a fragmentary, perspective view of the end effector of FIG.88 with the blade pushrod in a fully actuated state after cutting;

FIG. 90 is a fragmentary, longitudinally cross-sectional, perspectiveview of a distal end of the end effector of FIG. 85;

FIG. 91 is a fragmentary, longitudinally cross-sectional, perspectiveview of a distal end of the end effector of FIG. 89;

FIG. 92 is a flow chart of a process for completing a crimping procedurewith a multiple-firing crimping assembly; p FIGS. 93 to 101 areperspective and exploded views of an exemplary embodiment of a cord,cable, or suture securing clip with a rotatable locking assembly;

FIG. 102 is a fragmentary perspective view of the securing clip of FIGS.93 to 101 within a clip-delivery system in a loading orientation;

FIG. 103 is a fragmentary perspective and partially transparent view ofthe securing clip and clip-delivery system of FIG. 102;

FIG. 104 is a fragmentary perspective view of the securing clip anddelivery system of FIG. 102 within the securing clip in a partiallylocked state;

FIG. 105 is a fragmentary perspective view of the securing clip anddelivery system of FIG. 102 within the securing clip in a partiallylocked state;

FIG. 106 is a fragmentary perspective view of the securing clip anddelivery system of FIG. 102 within the securing clip deployed out fromthe distal end of the delivery system;

FIG. 107 is a fragmentary perspective view of the securing clip anddelivery system of FIG. 102 within a second securing clip advancedtoward the distal end of the delivery system;

FIG. 108 is a fragmentary perspective view of the second securing clipand delivery system of FIG. 107 enlarged;

FIG. 109 is a fragmentary, transparent perspective view of the secondsecuring clip and delivery system of FIG. 107 enlarged;

FIG. 110 is a perspective view of an exemplary embodiment of anothersecuring clip not to scale with a rotatable locking assembly in anunlocked state;

FIG. 111 is a perspective view of the securing clip of FIG. 110 with arotatable locking assembly in a partially locked state;

FIG. 112 is a perspective view of the securing clip of FIG. 110 with arotatable locking assembly in a locked state;

FIG. 113 is a bottom plan view of the securing clip of FIG. 112;

FIG. 114 is a bottom plan view of the securing clip of FIG. 110 with therotatable locking assembly in an unlocked state with a cord insertedtherein;

FIG. 115 is a bottom plan view of the securing clip of FIG. 114 with therotatable locking assembly in a partially locked state;

FIG. 116 is a bottom plan view of the securing clip of FIG. 114 with therotatable locking assembly in a locked state;

FIG. 117 is a perspective view of an exemplary embodiment of a furthersecuring clip not to scale with a press-fit locking assembly in aseparated state;

FIG. 118 is a perspective view of the securing clip of FIG. 117;

FIG. 119 is a perspective view of the securing clip of FIG. 117 in apartially fitted state;

FIG. 120 is a perspective view of the securing clip of FIG. 117 in afurther partially fitted state;

FIG. 121 is a perspective view of an exemplary embodiment of still afurther securing clip not to scale with a press-fit locking assembly ina disassembled state;

FIG. 122 is a perspective view of the securing clip of FIG. 121 with theclip in an assembled state and the press-fit locking ring disassembled;

FIG. 123 is a perspective view of the securing clip of FIG. 121 with theclip clamping a cord and with the press-fit locking ring not shown;

FIG. 124 is a perspective view of the securing clip of FIG. 123 with thepress-fit locking ring partially installed; and

FIG. 125 is a perspective view of the securing clip of FIG. 123 with thepress-fit locking ring installed.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments of the present devices and methods aredisclosed herein; however, it is to be understood that the disclosedembodiments are merely exemplary of, which can be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present devices and methods in virtually anyappropriately detailed structure. Further, the terms and phrases usedherein are not intended to be limiting; but rather, to provide anunderstandable description of the devices and methods. While thespecification concludes with claims defining the features that areregarded as novel, it is believed that the devices and methods will bebetter understood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward.

Alternate embodiments may be devised without departing from the spiritor the scope of the devices and methods. Additionally, well-knownelements of exemplary embodiments of the devices and methods will not bedescribed in detail or will be omitted so as not to obscure the relevantdetails thereof.

Before the present devices and methods are disclosed and described, itis to be understood that the terminology used herein is for the purposeof describing particular embodiments only and is not intended to belimiting. The terms “a” or “an”, as used herein, are defined as one ormore than one. The term “plurality,” as used herein, is defined as twoor more than two. The term “another,” as used herein, is defined as atleast a second or more. The terms “including” and/or “having,” as usedherein, are defined as comprising (i.e., open language). The term“coupled,” as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically.

Relational terms such as first and second, top and bottom, and the likemay be used solely to distinguish one entity or action from anotherentity or action without necessarily requiring or implying any actualsuch relationship or order between such entities or actions. The terms“comprises,” “comprising,” or any other variation thereof are intendedto cover a non-exclusive inclusion, such that a process, method,article, or apparatus that comprises a list of elements does not includeonly those elements but may include other elements not expressly listedor inherent to such process, method, article, or apparatus. An elementproceeded by “comprises . . . a” does not, without more constraints,preclude the existence of additional identical elements in the process,method, article, or apparatus that comprises the element.

As used herein, the term “about” or “approximately” applies to allnumeric values, whether or not explicitly indicated. These termsgenerally refer to a range of numbers that one of skill in the art wouldconsider equivalent to the recited values (i.e., having the samefunction or result). In many instances these terms may include numbersthat are rounded to the nearest significant figure.

The terms “program,” “software,” “software application,” and the like asused herein, are defined as a sequence of instructions designed forexecution on a computer system. A “program,” “software,” “application,”“computer program,” or “software application” may include a subroutine,a function, a procedure, an object method, an object implementation, anexecutable application, an applet, a servlet, a source code, an objectcode, a shared library/dynamic load library and/or other sequence ofinstructions designed for execution on a computer system.

Herein various embodiments of the present devices and methods aredescribed. In many of the different embodiments, features are similar.Therefore, to avoid redundancy, repetitive description of these similarfeatures may not be made in some circumstances. It shall be understood,however, that description of a first-appearing feature applies to thelater described similar feature and each respective description,therefore, is to be incorporated therein without such repetition.

Described now are exemplary embodiments. Referring now to the figures ofthe drawings in detail and first, particularly to FIGS. 1 to 35, thereis shown a first exemplary embodiment of a multiple-firing crimp device1. FIG. 1 shows an end effector of the multiple-firing crimp device 1with a crimp assembly in a position ready to load a first crimp. Fromthe center to the exterior of the crimp assembly, the innermoststructure is a snare 10. In an exemplary embodiment, the snare 10 islaser cut out of a sheet of Nitinol or is a Nitinol wire and is heat setin a snare shape. Exemplary heat-set embodiments are shown in FIGS. 36to 38. The snare 10 has a very low profile sufficient to fit, as shownin FIG. 1, within a hollow tube having an inner diameter ofapproximately 0.025″. A loop 12 is formed in the snare 10 to provide alarge area in which the user has to thread the cords to be connectedtogether (e.g., ends of a surgical suture). For example, the loop 12 isapproximately ovular with a major axis approximately 1.25″ long and aminor axis approximately 1″ long. The snare 10 is formed with a distaltip 14 that is described in further detail below. Herein, various snaresare described and are equally applicable to temporarily secure a cord orcords. Shapes of the snares described herein are not exclusive and arenot to be taken as the only shapes and/or configurations possible forsnaring a cord/cords. Shapes can include closed or open loops, hooks,curves, or other shapes.

Surrounding the snare 10 is a crimp carriage 20. The crimp carriage 20has a central lumen 22 with an inner diameter of approximately 0.025″ tohouse therein the snare 10. One or more of the inner surface of thecentral lumen 22 and the snare 10 is lubricious so that the snare 10 canmove out from and back into the central lumen 22 with little frictionand without catching. As the snare 10 exits the central lumen 22, theloop 12 expands and forms its heat-set shape after the entirety of theloop 12 exits the distal end of the central lumen 22 (see, e.g., FIGS.36 to 38). The outer surface of the crimp carriage 20 has an exteriorthread 24. This exterior thread 24 is described in further detail belowwith regard to the crimps 30 and has a shape corresponding to aninterior thread 32 of each crimp 30. As such, the length of the exteriorthread 24 can be as long as the crimp carriage 20 but it can also beonly as long as is needed to thread the desired number of crimps 30thereon in series. Five of the crimps 30 are illustrated as threadedonto the crimp carriage 20 in FIG. 1 but the threads are only showndiagrammatically in FIG. 1 within one crimp 30 and half of a secondcrimp 30 (this is done for illustration purposes only). These threadsare present on the crimp carriage 20 at least for the length of all ofthe crimps 30 that are to be loaded on the carriage 20. Alternativelythe carriage can be smooth and have the crimps stacked up on it with aretention feature disposed on the end of the carriage that prevents thecrimps from falling off the end of the carriage. In such an embodiment,the crimps are biased toward the retention feature by a slide that is,itself, biased distally by a compression spring. The slide has amechanism that only allows it to slide distally along the carriage. Inthis way, the crimps are advanced into position and, once thedistal-most crimp is moved into the ready position, the stack ofremaining crimps index forward moving the next crimp into position.

Surrounding the crimp carriage 20 at the distal end of the device is theend effector body 40, which is best seen in FIGS. 17 to 22. The endeffector body 40 defines a crimp loading orifice 42 in which a crimp 30is loaded and, when loaded, is ready for firing. FIG. 1 does not show acrimp 30 in a loaded crimping position. A crimping device 50 is disposedat the orifice 42 and, in the exemplary embodiment shown, is positionedon opposing sides of the orifice 42. More particularly, an anvil 52 ispresent on one side of the orifice 42 and a hammer 54 is present on theother side of the orifice 42 opposite the anvil 52. The anvil 52 can beof a different material than the end effector body 40 or it can beintegral with the end effector body 40. A cutting assembly 60 is alsopresent at the end effector body 40. The cutting assembly 60, in theexemplary embodiment shown, includes a cutter 62 that is biased in anon-cutting position (shown) by a non-illustrated spring, for example.The cutter 62 is moved (e.g., rotated) by a cutter push-rod 64, 66 thatextends back to the handle 100 of the multiple-firing crimp device 1;the handle 100 is diagrammatically shown in FIG. 3, for example, and isacutated by any number of actuation mechanisms, such as a motor, arelay, a lever, and/or a rack-and-pinion. To bias at least one of themovement assemblies in a proximal direction, a bias device 3 is providedand is diagrammatically shown in the handle 100 adjacent the movementassemblies. In this example, the bias device 3 is a spring.

An outer tube 70 surrounds the end effector body 40 and surrounds atleast part of the cutting assembly 60 as it moves distal and proximalwith respect to the end effector body 40. Also disposed within the outertube 70 is a suture lifter 80, which is explained in further detailbelow.

To explain how the multiple-firing crimp device 1 operates, reference ismade to the progression of FIGS. 2 through 31. The multiple-firing crimpdevice 1 comes pre-loaded to the user with a number of crimps 30 on thecrimp carriage 20. This number is sufficient to accomplish a particularprocedure. For example, if a heart valve replacement is the procedureand there are nine, twelve, or fifteen sutures needed to fix thereplacement heart valve within the native valve orifice (this assumes aneven spacing on a tri-leaflet valve), then the crimp carriage 20 will befitted with nine, twelve, or fifteen crimps 30 (e.g., six crimps 30 areshown on the crimp carriage 20 in FIG. 4).

When the multiple-firing crimp device 1 is loaded with crimps 30 and isready to use, the movement devices of the various loading/retracting,crimping, and cutting sub-assemblies within the handle 100 will be at afirst rest or start position. These assemblies are showndiagrammatically within FIGS. 3, 5, 7, 9, 11, 12, 16, 20, 24, 26, 29,and 31. Ways that each of the movement sub-assemblies can actuate thevarious tasks of the multiple-firing crimp device 1 include anycombination of levers, motors, relays, and other mechanical structures,such as a rack-and-pinion. Thus, they are not described in furtherdetail. Here, each of the movement sub-assemblies includes a movementspool as an exemplary structure for actuating the assembly, each ofwhich will be identified when the particular movement assembly isreferenced herein. Spools are used to allow for longitudinal translationwith free rotation.

When the multiple-firing crimp device 1 is loaded with crimps 30 priorto use, as shown in FIGS. 2 and 3, the crimp carriage 20 is retractedproximally out of the end effector body 40. Thus, the carriage spool 29is in the furthest retracted position (i.e., proximal or closest to theuser). In this state, the cutter 62 is retracted and the hammer 54 is inits steady or resting state away from the anvil 52. Significantly, nocrimp 30 is loaded within the crimp orifice 42. In this state, the snare10 is also retracted with the crimp carriage 20 and, therefore, thesnare spool 19 is in the furthest retracted position as well.

To load the multiple-firing crimp device 1 with a crimp 30 and make itready for use, the crimp carriage 20 is extended distally. This is doneby placing the carriage spool 29, along with the snare spool 19, in theposition shown in FIG. 5. In this step, the snare spool 19 can befree-floating because the carriage spool 29 (having a shaft within ashaft attached to the snare spool 19) forces the snare spool 19 distallyas far as the carriage spool 29 is moved. To secure the distal-mostcrimp 30′ within the crimp orifice 42, the head 34 of thesoon-to-be-loaded crimp 30′ must pass the distal ends of the hammer 54and the anvil 52, a state that is shown in FIG. 4. To describe how thecrimp 30′ is loaded into the crimp orifice 42 and held there, it isbeneficial to first describe an exemplary embodiment of a crimp 30,which is shown in FIGS. 32 and 33. To thread the crimp 30 onto theexternally threaded crimp carriage 20, the crimp 30 defines a borehaving internal threads 32 corresponding to the external threads 24 ofthe crimp carriage 20. In this way, each crimp 30 can simply be placedin loading position at the distal end of the crimp carriage 20 androtation of the crimp carriage 20 in a particular direction seriallyloads each crimp 30 thereon one after the other, as shown, for example,in FIG. 1. To prevent the crimps 30 from rotating while the crimpcarriage 20 is rotating, each crimp 30 has a head 34 formed with atleast one polygonal surface 36. The end effector body 40 has acorresponding shape to the polygonal surface that acts as a structure tokeep each crimp 30 aligned therewithin and prevent rotation of the crimp30. The crimp 30 has various advantageous characteristics. First, itsshape delivers the highest clamp force density. Next, it presents aclosed profile that houses the cord(s) therein. Finally, it is easilydeformed to restrain the cord(s) therein in a reliable and securemanner.

Once the crimp carriage 20 is retracted from the crimp 30′, it would,without more, rest within the crimp orifice 42 and, potentially, couldfall out with movement of the multiple-firing crimp device 1.Accordingly, to positively lock the crimp 30′ within the crimp orifice42, each crimp 30 is provided with a catch 38, which can take any shapeand, in the exemplary embodiment shown, is a transverse groove or cutadjacent a proximal side of the head 34 (the top side of the head 34 inthe view of FIG. 33). The catch 38 can be any shape or structure andneed not be the shape depicted in the figures. The catch 38 can be ahole or other depression but it can even be an extension such as aprotruding boss. To effect a catch-and-securement of the crimp 30′within the crimp orifice 42, the hammer 54 is provided with a distalfeature 56 having a shape that, when aligned with the catch 38, matestherewith. See, e.g., FIG. 6A. In the exemplary embodiment, the distalfeature 56 is a protruding nose having a longitudinal length shorterthan the longitudinal length of the catch 38. In this way, when the head34 of the crimp 30′ passes the distal feature 56 and is then retractedjust slightly proximal, the distal surface of the distal feature 56abuts the proximal surface of the head 34 and extension of the distalfeature 56 into the catch prevents both proximal and distal movement.Thus, along with the polygonal surface 36, the crimp 30′ is held inplace in all dimensions as shown in FIGS. 6 and 6A. The distal end inFIG. 6A shows the interaction of the catch 38 and the distal feature 56and the contact with both the distal faces of the hammer 54 and theanvil 52 to provide a proximal stop for the crimp 30′.

It is desirable to provide additional holding force on the crimp 30′ toretain the crimp 30′ therein. Accordingly, the hammer 54, which isshaped as a flex beam secured distally to the end effector body 40 atone or more contact points 58, has an interiorly extending section 53that acts as a cam along the edge of the crimp 30′. As shown, forexample, in FIGS. 13 and 25, when the outer tube 70 is moved distally,the distal end 72 acts as a cam driver by riding along the outer surface55 (a cam surface) of the hammer 54, thereby radially forcing the hammer54 inwardly. As such, with the distal end 72 of the outer tube 70preventing the intermediate portion of the hammer 54 from flexingoutward, the remaining exposed portion 74 of the distal end of thehammer 54 flexes radially outward and, thereby, imparts a strongradially inward bias against the crimp 30′. The position of the crimpcarriage 20 and the snare 10 in this state defines the correspondingpositions of the carriage spool 20 and the snare spool 19 that are shownin FIG. 7.

Now that the crimp 30′ is in position for use, in order to thread thecords into and through the hollow center of the crimp 30′, the snare 10is extended distally through the crimp 30′ with the tip 14 of the snare10 moving distally away from the distal end of the end effector body 40.As the tip 14 moves further distally, the loop 12 is permitted to opento its pre-set shape (e.g., heat-set), an example of which is shown inFIG. 8. Extension of the snare 10 occurs by moving the snare spool 19distally away from the carriage spool 29, as shown in FIG. 9. At thispoint, the cords can be inserted through the loop 12 for entry into andthrough the crimp 30′. However, the crimp 30′ is still attached to thecrimp carriage 20. Accordingly, the crimp carriage 20 is rotated (by anon-illustrated device that spins the carriage spool 29, for example) todisengage the crimp 30′ from the distal end of the crimp carriage 20. Atthe same time or either before or after, the crimp carriage 20 is moveddistally out of the end effector body and is rotated further to causethe distal end thereof to move and place the previously second crimp 30″in line into the distal-most crimp position, thereby converting thesecond crimp 30″ into the next crimp 30′ to be used for the nextcrimping procedure. The depiction in FIG. 10 illustrates the endeffector with the crimp carriage 20 entirely disengaged from thedistal-most crimp 30′ and retracted out of at least a portion of the endeffector body 40 to not interfere with subsequent steps (even though itis shown completely out of the view of FIG. 10, this does not mean thatsuch a distant retraction is required. It is sufficient if the carriage20 is retracted sufficiently far enough to not interfere with subsequentsteps prior to loading the next crimp 30′. The orientation of the snareand carriage movement sub-assemblies for this state is depicted with thepositions of the snare spool 19 and the carriage spool 29 in FIG. 11.

In the example of FIG. 12, the free ends 2′ of a looped cord 2 arepassed through the loop 12 (from the left to the right in the drawing).At this point, the cords 2 are ready to be threaded through the crimp30′. The snare 10 is drawn proximally to catch the cords 2 within theloop 12 and then in the tip 14, which, in an exemplary embodiment, formsa small extension area of the interior of the loop 12 in which the cords2 are moved as the loop closes and moves proximally. As the proximal endof the loop 12 is drawn proximally into the crimp 30′, the loop 12compresses flat, as in the orientation of FIG. 6, and the cords 2 are,then, folded in half and reside within the interior of the tip 14.Further proximal movement draws the cords 2 through the crimp 30′ asdepicted in FIG. 13. The looped ends of the cords 2 in the tip 14 aredrawn in further proximally into the device as shown in FIG. 14 untilthe free ends 2′ of the cords 2 enter the end effector body 40, as shownin FIGS. 15 and 17. The orientation of the snare and carriage movementsub-assemblies for this state is depicted with the positions of thesnare spool 19 and the carriage spool 29 in FIG. 16.

Now that the cords 2 are through the crimp 30′ and the ends 2′ arepulled sufficiently far enough into the shaft of the device, the processfor presenting these ends 2′ to the user begins.

FIGS. 17 to 24 illustrate this process with an exemplary embodiment of acord-lifting device 170, which is one possible way to present the ends2′ to a user. The cord-lifting device 170 is fastened to the endeffector body 40 at a pivot 172 so that the cord-lifting device 170 isable to pivot away from the central axis of the outer tube 70. With thispivot 172, when the cord-lifting device 170 is actuated, thecord-lifting plate 174 pivots to lift the cords 2 out of the outer tube70 through a window or lateral opening 171, as shown in FIG. 18. Thelifting can be effected with any mechanism, for example, a push rodextending from the handle 100 and attached in an intermediate positionof the cord-lifting plate 174 or extending adjacent the pivot 172 toconnect to a lever that lifts the cord-lifting plate 174 when eitherpushed or pulled. This actuation device is not depicted for drawingclarity. At this point, the snare 10 still grasps the cords 2.Accordingly, either the snare 10 can move distally to keep retention ofthe cords 2, as shown in FIG. 18, or the snare 10 can remain in placeand, as the cord-lifting device 170 lifts the cords 2 outwards, eitherthe length of the cords 2 distal of the crimp 30′ are pulled into thecrimp 30′ or the ends 2′ of the cords 2 are caused to shorten theirdistance from the tip 14 of the snare 10. FIG. 19 illustrates the liftedcords 2 still attached to the snare 10 and the cord-lifting device 170lifted. FIG. 20 illustrates the positions of the various movementsub-assemblies for this state.

As the snare 10 is pulled further distally, the ends 2′ of the cords 2become freed therefrom and now rest outside the outer tube 70 of thedevice. The user can, therefore, grasp these ends 2′ and, after thecord-lifting device 170 is lowered, can pull them taut as shown in FIGS.22 and 23. At this point, the snare 10 can be retracted in the device asshown in FIG. 24 by the position of the snare spool 19. Now, the crimp30′ can be installed/crimped/deformed on the cords 2.

Movement of the distal end of the device with respect to the oppositeends of the cords 2 held by the user (not illustrated but to the lowerleft of FIG. 23) will depend on the location that the user desires tofix the crimp 30′. If the current location is sufficient, then crimpingwill occur with the length of the cords shown to the lower left of FIG.23 remaining as is. However, if the distance from the opposite ends ofthe cords 2 is desired to be short, then the user will move the devicedistally along the cords 2 while holding onto the free ends 2′ andkeeping them taut. If, for example, the cords 2 are surgical sutures andthe opposite ends of the cords 2 are fixed at a surgical location, andif the surgeon wishes to have the crimp 30′ be applied as close to thesurgical location as possible, then the top of the head 34 of the crimp30′ will be moved along the sutures distally and up against the surgicalsite. When there, with tension on the sutures, the surgeon can fix thecrimp 30′ at a location closest to the surgical site.

Crimping occurs by moving the outer tube 70 distally, which is indicatedin FIG. 26 by the distal movement of the crimp spool 79. As the distancefor crimping the crimp 30′ is very short, the crimp spool 79 needs toonly move a short distance distally. This movement can be causedmanually by a lever, a toggle, or a button, for example, or by anelectrical motor, such as a stepper motor. Crimping occurs by the outersurface 55 of the hammer 54 acting as a cam profile with the distal endof the outer tube 70. As the outer tube 70 moves distally parallel tothe longitudinal axis of the device, the rising cam surface with respectto the outer tube 70 causes the hammer 54 to press inwards against thecrimp 30′ with a force sufficient to deform the crimp 30′ and fix it tothe cords 2, as shown in FIGS. 25, 34, and 35. In this state, the crimp30′ is crimped and, thereby, fixed to the cords 2 therewithin (showndiagrammatically with the dashed line in FIG. 35). For ease ofvisualization, FIG. 27 illustrates the hammer 54 in the crimpingposition without the crimp 30′ present.

It is noted that the internal threads 32 of the crimp 30′ provideadditional friction and holding power when crimped onto the cords 2. Theinternal threads of the crimp can be adjusted to not be full depththreads. The threads also can be adjusted to optimize the ID of thecrimp for clearance to pass the cords and snare as well as to present aless damaging but still gripping surface to the cords upon crimping. Thecatch 38 also provides crimp relief and length reduction for when thecrimp 30′ is squeezed. The distal-most section of the crimp 30′ remainsundistorted to provide a smooth transitional surface that the cords 2can follow to prevent high stress that might damage the cords 2.

After crimping occurs, the lengths of the cords 2 on the proximal sideof the fixed crimp 30′ are to be trimmed off. The cutting assembly 60described above is able to cut the cords 2 with a cutter pushrod havinga relatively stiff proximal portion 64 and a relatively flexible distalportion 66 that is able to bend as the pivoting blade 62 moves (see, forexample, FIG. 28). As such, cutting of the cords 2 occurs when anactuator at the handle 100 causes the proximal portion 64 to movedistally. This, in turn, causes the distal portion 66 to move distallyand, because it is fixed to the proximal side of the blade 62, causesthe blade 62 to move about its pivot point and allow the cutting edge 68to sever the cords 2. As the blade 62 is only required to move a veryshort distance, the distance that the cutting rod 64, 66 needs to moveis also very short and is illustrated by the relative positions of thecutting spool 69 in FIGS. 26 and 29. It is noted that the outer tube 70and tube spool 79 also move along with the cutting spool 69, but thismovement is optional. In order to assure cutting is complete and thedevice is unobstructed for use of the next crimp 30, the cuttingmovement assembly is biased proximally (e.g., with a spring) toautomatically retract the knife 62 after a cut is complete.

This cutting configuration of the cutter assembly 60 is merely oneexemplary embodiment. Another embodiment can include a pusher that cutsthe cords 2 by pressing the cords 2 against a fixed blade as describedin further detail below. A further embodiment can have the knife cutagainst a cut block or stop. Yet another embodiment can apply electriccurrent to the knife and allow it to cut as a hot wire. In any case, itis desirable to have the knife cut close to location of the crimpedcrimp 30′ to reduce the remaining length of the cords 2 extending fromthe end of the crimp 30 opposite the head 34.

Like the cutting movement assembly, the movement assembly for the outertube 70 is biased proximally (e.g., with a spring, even the same springas the cutting movement assembly) to automatically retract the outertube 70 after a crimp 30′ fixation is complete. In this way, the hammer54 is allowed to spring back to its ready-to-crimp position when theouter tube 70 is disengaged.

An alternative to the loop 12 of the snare 10 is a hook needleconfiguration shown in FIGS. 39 to 41. Instead of the loop 12, the snare10 has a hook 13 that is able to catch and hold the cords 2 as shown inFIG. 41. Like the loop 12, the hook 13 is pulled proximally until theends 2′ of the cords 2 release from the hook 13 and become loose forpresentation to a user. The presentation can include the cord-liftingdevice 170, for example.

Another exemplary embodiment of a multiple-firing crimp device 200 isillustrated in FIGS. 42 to 56. In this multiple-firing crimp device 200,the crimp carriage 20 and the crimps 30 along with their respectivemovement sub-assemblies can be similar or identical to the previousembodiments described and shown. Thus, where identical structures arepresent, the same reference numerals may be used herein. Differentstructures, in contrast, have numbers with a prefix of two hundred. Inthe embodiment of FIGS. 42 to 56, the movement devices for placing andoperating the snare 10 are included within a shuttle 280 that is movablydisplaced along the outer tube 270. In order to keep the shuttle 280rotationally aligned in one orientation about the outer tube 270, theshuttle 280 and the outer tube 270 contain an alignment structure thatcan take many forms. One possible form is a tongue-and-groove in whichone of the shuttle 280 and the outer tube 270 has the groove and theother has the tongue. A further alignment device can attach a secondarytube or rod 570 to the bottom of the outer tube 270 and form a rail uponwhich a corresponding longitudinal orifice in the shuttle 280 slidablyresides. In such a configuration, the cross-section of the outer tube270 and rail can take the shape of an “8” (as shown in FIG. 57). Therail can have a different diameter than the diameter of the outer tube270, for example, it can be smaller. Alternatively the outer tube canhave a non-round profile such as an oval or a hexagon. It is noted thatall of the features of the handle 100 need not be illustrated and,therefore, only a diagrammatic portion of the handle 100 is shown.

The process for completing a crimp installation is described in thetransition from FIGS. 42 through 56, in which the various parts areintroduced. The steps of loading the crimp 30′ into the end effectorbody 240 and then withdrawing the crimp carriage 20 proximally forcrimping is not repeated or shown here for the sake of brevity. In thesefigures, the crimp 30′ has already been set into the end effector body240 and is ready to be used and crimped on cords 2.

In FIG. 42, the manually actuated shuttle 280 is in a fully retractedposition, in which position the steps of loading the crimp 30′ into theend effector body 240 and then withdrawing the crimp carriage 20proximally occurs. Accordingly, the first crimp 30′ is in a position foruse. FIG. 43 illustrates the shuttle 280 moving distally towards the endeffector body 240. In both the fully retracted and intermediatepositions almost to the distal end of the outer tube 270 (see FIGS. 44to 48), a snare-extension tube 212 resides outside the outer tube 270.

The shuttle 280 includes a snare-aligning assembly 282 and asnare-movement assembly 290, both of which are illustrated, for example,in FIG. 44. The snare-aligning assembly 282 pivots the snare-extensiontube 212 into and out of alignment with the central axis of the outertube 270 so that the distal end of the snare-extension tube 212 can beplaced adjacent or even enter the longitudinal cavity of the crimp 30′from the proximal side and, thereby, allow extension of the snare 210directly through the crimp 30′. The pivot of the snare-aligning assembly282 is disposed approximately at the midpoint of a vertical height ofthe shuttle body 281 and, because the outer tube 270 is present in thesefigures, the pivot is obscured from view. The pivoting action can beseen in the transition from FIGS. 48 to 49. The snare-aligning assembly282 is biased with a force from a bias device 283 that presses thesnare-extension tube 212 downwards against the outer surface of theouter tube 270. In this manner, the outer surface of the outer tube 270acts as a cam surface to the snare-extension tube 212.

Additionally, the snare-aligning assembly 282 also has a lock-out arm284 extending proximally from the bias device 283 and residing in apocket 291 of the snare-movement assembly 290. The lock-out arm 284 hasa proximal surface that opposes the distal-facing interior surface ofthe pocket 291 and, when the proximal end of the lock-out arm 284 isdisposed in the pocket 291, the proximal surface prevents distallongitudinal movement of a snare-extender slide 292 until the lock-outarm 284 exits the pocket 291. In this manner, until the snare-aligningassembly 282 is able to pivot the snare-extension tube 212 intoalignment with the crimp 30′, the snare-extender slide 292 islongitudinally fixed from moving distally.

FIGS. 46 and 47 illustrate the longitudinal positions of the shuttle 280on the outer tube 270 at which the pivoting movement of thesnare-aligning assembly 282 is made possible, which movement unlocks thesnare-extender slide 292. FIGS. 48 and 49 are close-up views of theshuttle 280 in its respective positions in FIGS. 46 and 47. Movement ofthe snare-extension tube 212 is dependent upon the exterior surface ofthe outer tube 270. Accordingly, to allow the distal end of thesnare-extension tube 212 to align with the lumen in which the crimpcarriage 20 travels, the outer tube 270 has a longitudinal slot 272. Theshape of the slot 272 acts as a track to guide and insert the distal endof the snare-extension tube 212 up to or into the proximal end of thecrimp 30′. As such, when the shuttle 280 passes the position on theouter tube 270 shown in FIG. 48, the snare-extension tube 212 enters theslot 272 and drops against and into the inner carriage lumen 271 of theouter tube 270, as shown in FIGS. 49 and 50. When this dropping movementoccurs, the pivot of the snare-aligning assembly 282 is complete and thelock-out arm 284 no longer impedes distal movement of the snare-extenderslide 292. In this state, the distal opening of the snare-extension tube212 is axially aligned with the center of the crimp 30′.

Also revealed in detail in FIGS. 48 and 49 is the crimp carriage 20carrying a set of crimps 30. In these views, eighteen crimps 30 areillustrated. This number, however, is only exemplary and the number canbe as little or as great as desired dependent upon the procedure beingcarried out. In these figures, the carriage lumen 271 has the polygonalshape to keep the crimps 30 aligned but this keying feature is notillustrated.

With the snare-extender slide 292 unlocked for distal movement,extension of the snare is now made possible. The snare 210 is differentfrom the above embodiments in that the distal end is no longer connectedto the handle 100. Here, in contrast, the snare 210 is connected, at itsproximal end, to a tab 293 that is fixed to or integral with thesnare-extender slide 292. As such, the longitudinal length of the snare210 (or its movement shaft) is significantly shorter than those in theprevious embodiments. In this manner, when the snare-extender slide 292moves distally, the snare 210 also moves distally. In these figures, thedistal portion of the snare with the loop 12 and the tip 14 are withinthe snare-extension tube 212 but are hidden for clarity. As the snare210 is relatively flexible and could possibly buckle when pusheddistally out of the snare-extension tube 212, a non-illustrated supporttube (typically polymer based) surrounds the proximal portion of thesnare 210 within the shuttle body 281. This support tube can be attachedto or be integral with the extender slide 292. The length of the supporttube should be such that the distal end of the support tube is not ableto be freed from the proximal end of the snare-extension tube 212, thuskeeping the two always aligned and preventing exit of the snare 210 fromeither.

The snare 210 can now be extended, as shown in FIGS. 51 and 53. As thesnare-extender slide 292 moves distally, the distal end of the snare 210emerges from inside the crimp 30′ and finally exits to the environmentdistal of the shuttle 280 so that the loop 12 opens to define an areainto which the cords 2 are inserted, as shown in FIGS. 52 and 54. InFIGS. 51 to 54, the tip 14 of the snare 210 is not illustrated forclarity.

It is undesirable for the shuttle 280 to move longitudinally in any waywhile the snare 210 is moving distally from the position shown in FIGS.49 and 50. Accordingly, movement of the shuttle body 281 is locked whenthe snare-extender slide 292 moves. Such a movement prevention device isnot illustrated in FIGS. 42 to 56, but there is one shown in FIG. 60, inwhich a spring clip 590 engages an opening in the shaft 270 (or 570)when the shuttle is in its distal-most snare-extending position. Themotion of the spring clip 590 into the opening frees the snare-extenderslide 292, allowing it to now move distally while simultaneously lockingthe shuttle 280 in the snare-extending position.

Once the cords 2 are inserted into the exposed and expanded loop 12 ofthe snare 10, retraction of the cords 2 through the center of the crimp30′ is now possible. To effect this retraction, the user moves thesnare-extender slide 292 proximally, in which position all but the tip14 is retracted back into the shuttle body 281, as shown in FIG. 57. Theorientation of the tip 14 while the snare-extender slide 292 is in itproximal-most position is illustrated in FIG. 57. At this point, aportion or all of the free ends of the cords 2 are still within the endeffector body 240 or are distal of the crimp 30′ while the cords 2 arethreaded through the tip 14. Now that the snare-extender slide 292 isproximal, proximal movement of the shuttle body 281 becomes possiblegiven the fact that the spring clip 590 is free to flex back to its homeposition outside the opening in the shaft 270, 570 (because theinterlock holding the shuttle body 281 has disengaged). The usercontinues retraction of the shuttle 280 with the snare and the coupledcords 2 proximally until the free ends 2′ pass entirely through thecrimp 30′, exit the shaft through slot 272, completely shorten, andfinally exit the tip 14, as is shown in the transition from FIG. 55 toFIG. 56.

At this point, the user is presented with the free ends 2′ outside theouter tube 270 and is now able to manually pull the free ends 2′ of thepreviously snared cords 2 tight and place the crimp 30′ adjacent to thedistal loop of the cords 2 (not illustrated but to the left of FIG. 56)where crimping is to take place. While pulling tightly on the free ends2′ of the cords 2, the user can place the distal end of the device wherethe crimp 30′ is being held at a cord-fixing location. Actuation devicesof the handle 100 (as described above) cause the crimp 30′ to compresson and fix the cords 2 together and, thereafter, also cut the cords 2just proximal of the crimped crimp 30′. The shuttle 280 is moved to itsstart position shown in FIGS. 42 and 44, thereby placing the device in aposition to load the next crimp 30″ into the crimp orifice 42.

The snare 10 is secured at its proximal end to the snare-extender slide292 (e.g., at tab 293) positioned adjacent the proximal end of theshuttle 280. Because the travel distance of the snare-extender slide 292is greater than or equal to the length of the snare that is to extendoutward from the shuttle 280 in the distal direction, the shuttle 280must have a longitudinal length that is dependent upon and is at leastas long as the length of that snare. In other words, the extension ofthe snare 10 by the snare-extender slide 292 is 1:1. If the length ofthe shuttle 280 requires it to have significant weight or to have alength that is greater than is needed, it would be desirable to providean assembly that permits a greater than 1:1 ratio and reduces thelongitudinal length and/or weight.

In the embodiments of FIGS. 58 to 74, the movement devices for placingand operating the snare 10 are included within a shuttle 580 that ismovably displaced along the outer tube 270. This shuttle 580 is able tobe shorter and lighter than the shuttle 280. To keep the shuttle 580rotationally aligned in one orientation about the outer tube 270, theshuttle 580 and the outer tube 270 contain an alignment structure thatcan take many forms. One possible form is a tongue-and-groove in whichone of the shuttle 580 and the outer tube 270 has the groove and theother has a tongue. A further alignment device can attach a secondarytube or rod 570 to the bottom of the outer tube 270 and form a rail uponwhich a corresponding longitudinal orifice in the shuttle 580 slidablyresides. In such a configuration, as shown in FIG. 58, the cross-sectionof the outer tube 270 and the rail 570 takes the shape of an “8”. Asabove, the rail 570 can have a different diameter than the diameter ofthe outer tube 270, for example, it can be smaller. It is noted herethat all of the features of the handle 100 need not be illustrated hereand, therefore, the handle 100 is omitted.

The shuttle 580 depicted in FIGS. 58 to 74 provides a snare extension toslide movement length in a ratio that is greater than 1:1 and, at thesame time, reduces the longitudinal length and weight of the shuttle580. These features are provided by removing the longitudinal tube fixedto the snare-movement slide and replacing it with a rack-and-pinionsnare-movement assembly having the snare wrapped around a snaredischarge spool. In this shuttle 580 for the multiple-firing crimpdevices herein, the crimp carriage 20 and the crimps 30 along with theirrespective movement sub-assemblies can be similar or identical to theprevious embodiments described and shown. Thus, where identicalstructures are present, the same reference numerals will be used herein.Different structures, in contrast, will have numbers with a prefix offive hundred.

FIGS. 58 and 59, respectively, depict the shuttle translating from aretracted position against the handle 100 to an extended position wherethe snare-extension tube 512 drops into the slot 272 of the outer tube270. FIGS. 60 to 62 illustrate the shuttle 580 in a state where thesnare-extension tube 512 has not reached the slot 272 and, therefore,still remains against the outer surface of the outer tube 270. Incomparison, FIGS. 63 to 65 illustrate the shuttle 580 in a state wherethe snare-extension tube 512 has dropped into the slot 272 and is readyto extend the snare within the outer tube 270 through the crimp 30′(which is not illustrated here). All of the steps for aligning thesnare-extension tube 512 are the same as above and, therefore, thedetails of which are not repeated here.

The body 581 defines an interior snare spool cavity 582 in which a snarespool 583 and a pinion 584 rotatably reside. The snare spool 583 isrotationally fixed to the pinion 584 so that rotation of the pinion 584results in a corresponding rotation of the snare spool 583. The snarespool 583 is illustrated in cross-section in FIG. 63. The body 581 alsodefines an interior rack cavity 585 in which a rack 586 resides forlongitudinal movement within the rack cavity 585. A distal end of therack 586 is fixed to the snare-extender slide 292, for example, it ispinned thereto at point 587. The snare 10, which is not illustrated inFIGS. 59 to 68 for purposes of clarity, has a proximal end that ispinned to the snare spool 583. In an exemplary embodiment of the snarespool 583 in FIG. 63, the snare spool 583 has a radial bore extendingradially inwards from a spool outer contact surface. The distal end ofthe snare 10 is positioned inside the bore and is fixed there, forexample, with a set screw or pin. The snare 10 is then wound around thesnare spool 583 (e.g., counterclockwise with respect to FIG. 63) on thespool contact surface and is threaded into the snare-extension tube 512.The spool sides are raised to have a diameter greater than a diameter ofthe spool contact surface to keep the snare 10 from sliding off thesnare spool 583 laterally.

With such a configuration, as the snare-extender slide 292 is moveddistally by the user, the rack 586 moves distally as well, therebyrotating the pinion 584 and the snare spool 583. Because the diameter ofthe pinion 584 is smaller than the diameter of the snare spool 583, thepinion 584 acts as a speed increasing gear to enable a larger movementof the snare spool 583 and, thereby, a length of the snare 10 that iswound about the snare spool 583. In particular, the overall length ofthe snare 10 is set to position the tip 14 just outside the distal endof the snare-extension tube 512 when the snare-extender slide 292 andthe rack 586 are in their proximal-most, unactuated position (shown inFIG. 63). This tip 14 position is shown, for example, in FIG. 57. As therack 586 moves distally, the snare spool 583 unwinds the snare 10 (e.g.,in a counterclockwise direction with regard to FIG. 63) and extends thesnare 10 out from the distal end of the snare-extension tube 512. FIGS.66 to 69 show the snare-extender slide 292 (and, therefore, the rack586) extended distally to the fullest extent to, thereby, move thenon-illustrated snare 10 out from the distal face of the shuttle 580.With the gearing shown, an approximately one inch (1″) movement of therack 586 causes approximately two and one-half inches (2.5″) of snare 10extension out from the distal end. Thus, the overall length of theshuttle 580 can be reduced significantly.

As indicated above, it is desirable to prevent the shuttle body 581 frommovement when the shuttle 580 is in a position where the snare 10 is tobe moved. Various retaining features can be provided. One example ofthis retaining feature is a body interlock 590. In this example, thebody interlock 590 is a leaf spring with an extension 593 that ridesalong the bottom surface of the guide rod 570 as the shuttle 580 movesand, when the shuttle 580 is in a position where snare 10 movement ispermitted, a port 592 in the guide rod 590 is located to catch theextension 593 of the body interlock 590 therein and substantiallyprevent longitudinal movement of the shuttle 580 on the outer tube 270.Once the leaf spring of the body interlock 590 is allowed to move intothe port 592, the free end 591 of the body interlock 590 moves out ofthe way of the extender slide 292, allowing the extender slide 292 tomove distally. It is noted that the wrap-around extender slide 292embodiment of FIGS. 58, 59, 66, and 70 to 74 entirely wraps around theshuttle body 581. In this configuration, the free end 591, is able topositively engage the extender slide 292 and prevent movement. Incontrast, the exemplary embodiment of the short extender slide 292 inFIGS. 60 to 65 and 67 to 69 does not wrap around to the bottom surfaceof the shuttle body 581. Thus, the configuration of the body interlock590 would not engage the short extender slide 292. For the shortextender slide 292 in FIGS. 60 to 65 and 67 to 69, the body interlock590 would be positioned behind the shaft 270, 570 in the figures and,therefore, would not be visible in these figures. Accordingly, the bodyinterlock 590 is left at the lower surface of the shuttle body 581 forpurposes of clarity only.

Once the extender slide 292 has moved any distance distally, it forciblyholds the leaf spring of the body interlock 590 in the port 592 therebylocking the shuttle 580 into the shuttle's distal-most position. Whenthe extender slide 292 is returned to its proximal position (e.g., FIG.60), the body interlock 590 remains engaged in the port 592. As the bodyinterlock 590 is a leaf spring with ramps on either side of theextension 593, a sufficient force by the user to move the shuttle 580proximally, overcomes the interlock and slides the extension 593 outfrom the port 592. In action, the body interlock 590 acts as a removabledetent that provides sufficient force to retain the shuttle 580 inposition when snare functions occur but that is insufficient to preventretraction movement of the shuttle 580 by a force imposed by the user.

When the devices described herein are used in surgery, the locationwhere the snare 10 is to capture cords 2 (e.g., sutures), is typicallywithin a surgical site. Even though there is light from the surgicalenvironment, many obstacles present shadows where the snare 10 islocated during use. The color and size of the snare 10 also can make itdifficult for a surgeon to see the snare 10 within the background of thesurgical site. To alleviate this issue, the shuttle body 581 is providedwith a distal headlight assembly 550. One or both of the sides of theshuttle body 581 is hollowed out and provided with a cover 551 tocontain parts of the headlight assembly 550, as shown in FIGS. 70 to 74.The cover 551 is made transparent in FIG. 71 to show thereunder a powersupply 552 (in the form of one or more coin cells) and a headlamp switch553, which is, in this exemplary embodiment, a micro-switch having theswitch on a proximal side thereof with the body of the micro-switchpositioned flush with an end-of-travel surface 710 of the shuttle body581 for the snare-extender slide 292 and with the switch plungerprojecting distally from the end-of-travel surface 710. In such aconfiguration, when the snare-extender slide 292 reaches a point wherethe snare 10 is extended for snaring one or more cords (as shown in FIG.74), the switch automatically depresses, thereby turning on the headlamp554, which can take the form of one or more LEDs, for example. In thisconfiguration, the headlamp 554 remains on until the snare-extenderslide 292 is retracted proximally, in which case the snare 10 is withinthe shuttle 580 and has captured the one or more cords 2.

The shuttle body 581 is not limited to the shapes shown hereinabove.There are other configurations in which various characteristics aremaximized or minimized. FIGS. 75, 75A, and 75B illustrate an exemplaryembodiment of a shuttle body that allows the snare-extender tube to berelatively straight and positions the snare's exit from the snare spoolfrom above the snare spool instead of below. FIGS. 76, 76A, and 76Billustrate an exemplary embodiment of a shuttle body configuration thatremoves some of the body material to lighten the shuttle and places thesnare-extender slide only on the bottom half of the shuttle. A headlightassembly is also provided. The exemplary configuration in FIGS. 77, 77A,and 77B removes even more material from the shuttle body to furtherlighten the shuttle. The exemplary configuration of the left half of theshuttle body in FIGS. 78, 78A, and 78B is similar to the shuttle bodyembodiment of FIGS. 58 to 74 and shows differences in configuration,size, and material from the other shuttle bodies.

An exemplary embodiment of a handle 100 for the multiple-firing crimpdevice is illustrated in FIGS. 79 and 80, in FIG. 80, the carriagemovement assembly is transparent to illustrate the structures therein.Within the handle 100 are various movement assemblies. Some of themovement assemblies are manual and some are automatic. As set forthherein, any of the automatic movement assemblies shown and described canbe manual and any of the manual movement assemblies shown and describedcan be automatic. In this handle embodiment, the movement assembliesinclude a system control assembly 800, a carriage movement assembly 810,a carriage rotation assembly 820, a crimping assembly 840, a cuttingassembly 860, and a display assembly 880.

The system control assembly 800 includes all circuitry sufficient topower and control all electronics on the multiple-firing crimp device.The system control assembly 800 is electrically connected to a powersupply 802, which can be, for example, a pack of batteries, such as oneor more CR2 or CR123 batteries. The power supply 802 can be powered byany electricity delivery measures including a supply mains.

The carriage movement assembly 810 includes a carriage conveyor 812 witha transparent cover that is best shown in FIG. 80. Also included in thecarriage movement assembly 810 is a carriage motor 814 fixed to thehandle 100 and rotating a conveyor spindle 816 that, when rotated,either moves the carriage conveyor 812 proximally or distally withrespect to the handle body 102. The carriage conveyor 812 has a rotationsub-assembly 820 that, at its distal end, includes a coupler 824 that isrotationally and longitudinally fixed to the crimp carriage 20. As such,when the carriage conveyor spindle 816 rotates and causes the conveyor812 to move proximally or distally, the crimp carriage 20 movescorrespondingly with the coupler 824. In this regard, the carriage motor814 is the device that positions the crimp(s) 30 towards and away fromthe crimp orifice 42 as well as positions the crimp 30′ within the crimporifice 42. Two non-illustrated limit switches are present in thecarriage movement assembly 810 to define the extension and retractionlimits of carriage conveyor 812 and, thereby, the crimp carriage 20.

The carriage rotation assembly 820 is part of the carriage movementassembly 810 and resides inside the carriage conveyor 812. The carriagerotation assembly 820 comprises a carriage rotation motor 822 and thecoupler 824, which is rotationally fixed to the output of the carriagerotation motor 822. As such, when the carriage rotation motor 822rotates, the crimp carriage 20 rotates to shuttle the crimps 30 and towithdraw from the crimp 30′ within the crimp orifice 42. Electricalsignals/power are supplied to the carriage rotation assembly 820 througha movable wiring harness 818 that is electrically connected to the maincircuit board of the system control assembly 800.

The crimping assembly 840 includes a crimping motor 842 fixed to thehandle body 102 and rotationally connected a crimping pinion 844. Theteeth of the crimping pinion 844 mesh with teeth of a flying gear 846.The flying gear 846 has a central bore with an interior threadcorresponding to an exterior thread of a crimping clutch 848. Movementand functionality of the crimping clutch 848 is described with regard toFIGS. 81 to 84. In particular, there are two states in which the outertube 70, 270, 570 is to be moved. The first is slightly forward so thatthe hammer 54 is gently pressed against the crimp 30′ to hold it withinthe crimp orifice 42 and to not deform the crimp 30′ and the second isforward to have the hammer 54 actively deform and fully crush the crimp30′. To provide the first function of gently pressing the crimp 30′, aclutch bias 850 (in the exemplary form of a spring) is disposed betweena distal end of the crimping clutch 848 and a point on the outer tube70, 270 a distance away from the distal end of the crimping clutch 848.This point is defined by a clutch stop 852 that has a proximal verticalsurface 854 intended to contact the distal vertical surface of thecrimping clutch 848 and prevent it, after such contact, from movingindependent of the outer tube 70, 270. The clutch stop 852 can be simplya radial extension from the outer surface of the outer tube 70, 270,such as an integral collar, which is not adjustable, or it can be anadjustable clutch stop 852, 854, 856 that is formed on or is integralwith the outer tube 70, 270 and has, for example, exterior threads 852and a nut 856 threaded thereon as shown in FIGS. 81 to 84. With theclutch bias 850 disposed between the distal vertical surface of thecrimping clutch 848 and the proximal vertical surface of the nut 856,the crimping clutch 848 is able to move asymmetrically with respect tothe outer tube 70, 270 as it compresses the clutch bias 850. In thisregard, with the clutch stop 852 disposed just distal of the distal endof the crimping clutch 848 to define a clutch distance therebetween andthe clutch bias 850 therearound this intermediate portion, as thecrimping clutch 848 starts to move distally (as shown in the transitionfrom FIG. 81 to FIG. 82), the clutch bias 850 starts to compress andonly moves the outer tube 70, 270 with a force that is proportional tothe clutch bias 850. This force is set to be lower than the point atwhich the hammer 54 actually compresses the crimp 30′. In FIG. 82, forexample, the crimping clutch 848 moves distally slightly (as compared toFIG. 81), compresses the clutch bias 850 and, thereby, moves the outertube 70, 270, 570 distally but only with the force that compressed thespring. In the transition from FIG. 82 to FIG. 83, the crimping clutch848 closed the distance and contacted the proximal vertical surface ofthe clutch stop 852. Because the spring of the clutch bias 850 has acoefficient less than a force able to compress the crimp 30′, the springis compressed without further movement of the outer tube 70, 270, 570 inthis transition. However, after the crimping clutch 848 contacts theproximal vertical surface of the clutch stop 852, any further movementof the crimping clutch 848 corresponds to a 1:1 movement of the outertube 70, 270, 570 and, thereby, causes movement of the outer tube 70,270, 570 and crimping of the crimp 30′.

A limit switch 858 is present adjacent the crimping clutch 848 todetermine when the crimping clutch 848 has reached it furthest distancefrom the flying gear 846 and indicates to the system control assembly800 that the crimping motor 842 should be stopped and prevent furtherturning of the flying gear 846. Also, to prevent the crimping clutch 848from rotating with respect to the handle body 102, a keying assembly 859is provided. This keying assembly can take the form of a pin and slottedblock, a tongue-and-groove, or any similar rotation-preventing device.

As is indicated, the crimping assembly 840 is automated with the variousmotors and gears. The crimping process is started by depressing anon-illustrated trigger button disposed in a button orifice 857 of thehandle 100. When this button is pressed, crimping of the crimp 30′occurs. The crimping assembly 840 holds the crimp 30′ down and waits toreset the next crimp 30″ until there is confirmation that the cords 2have been cut, at which time a new crimp 30′ is transitioned to thecrimp orifice 42. Associated with the cutting assembly 860 is anon-illustrated limit switch that indicates a position at which thecutting blade is known to be or past a point where the cords 2 could beor the cutting blade pushrod is known to be or past the cutting tip of afixed blade. When this limit switch is triggered, the crimping assembly840 retracts to the crimp-ready position. An exemplary embodiment of anend effector portion of the cutting assembly 860 having a moving pushrodand a fixed blade is explained below with regard to FIGS. 85 to 91.

Exemplary embodiments of a handle portion of the cutting assembly 860are shown in FIGS. 81 to 84. With particular reference to FIG. 84, thehandle portion of the cutting assembly includes a lever 862 with akidney-shaped slot having, at a distal surface thereof, teeth 864 thatare each disposed on a fixed radius from a pivot point 866 of the lever862. Centrally fixed but rotatably disposed with respect to handle body102 is a gear assembly 868 having a smaller gear interfacing with theteeth 864 and a larger gear interfacing with a rack 870. In thisconfiguration with the smaller and larger gears of the gear assembly868, closing the lever 862 onto the handgrip 104 of the handle 100causes a distance-multiplied linear translation of the rack 870. Therack 870 is fixedly connected to the cutter push rod 64, therebyeffecting a distal displacement of the cutter push rod 64 when the lever862 is closed.

An alternative embodiment to the rotating cutter described above is alinear cutter shown in FIGS. 85 to 91. FIGS. 85, 86, and 90 illustratean end effector of a multiple-firing crimp device with a fixed blade 890and a blade pushrod 892 in a fully retracted position and with thecrimping assembly 840 in a non-crimping state, in other words, the outertube 70, 270 is retracted. FIG. 87 shows the crimping assembly 840 in acrimped state with the outer tube 70, 270 extended to crimp the crimp30′. FIG. 88 shows the blade pushrod 892 in a partially actuated statebefore cutting occurs. It is noted from the right side of FIG. 88 thatthe blade pushrod 892 is a tube that rides inside the outer tube 70,270. To insure that the cords 2 are pressed against the fixed blade 890,the slot in which the cords 2 extend out the side of the outer tube 70,270 narrows at a distal end 893 and terminates at the tip of the blade890. FIGS. 89 and 91 show the blade pushrod 982 in a fully actuatedstate after cutting has occurred. (Due to limitations of the graphicssoftware, the inwardly compressed hammer 54 in FIG. 91 is shown withinthe crimp 30′.)

The display assembly 880 is connected to the system control assembly 800and, in this exemplary embodiment, is shown as an LED, which can be, forexample, an RGB LED that can produce light in various colors, eachdistinct color (or even a flashing pattern) is able to indicate aparticular function or status. The display assembly 880, in analternative embodiment, can be an LCD or LED or OLED display panel thatcan produce any colors, text, video, or pictures indicating status orany other characteristic of the multiple-firing crimp device.

FIG. 92 shows a flow chart of a process for completing a crimpingprocedure with a multiple-firing crimp device described herein. In orderto initialize the device, the outer tube and the crimp carriage areretracted. It is assumed that the crimps come preloaded on the crimpcarriage before it is passed to a user. Of course, there can be apre-initialization requirement that has the user load the crimpcarriages with the crimps. Once initialized, the first crimp (thedistal-most one) is advanced to the crimp loading orifice. The firstcrimp is secured at the crimp loading orifice by advancing the outertube to gently press the hammer against the first crimp and hold it inthe orifice. The crimp carriage is then rotated out from the first crimp(e.g., by a predefined number of turns) and further rotated to put thesecond crimp into a first crimp position at the distal end of the crimpcarriage. The crimp carriage is moved proximally away from the endeffector sufficiently far to prevent any interference with the crimpingprocedure into an idle position. The second crimp alignment can occurbefore, during, or after movement of the crimp carriage. As one crimp isno longer on the crimp carriage, the system can decrement a counter tokeep track of the number of remaining crimps. At this point, the deviceis ready to use.

The user then carries out the manual steps of extending the snare,capturing the cord(s) within the snare, retracting the snare back tohold the cord(s), and then lifting the cord lifter or moving the shuttleproximally to present the end of the cord(s) outside the shaft of thedevice. The user grasps the exposed free end(s) of the cord(s) and pullsit/them taut. The end effector is then moved distally along the cord(s)to the place where the user desires to set the crimp. For example, wherethe cord is a surgical suture, the crimp is desired at the surgical sitewith no length of the suture between the crimp and the tissue. In such acase, the user will move the end effector up against the tissue to makethe crimp ready to be fixed.

The automatic crimping can now occur. The user presses the crimp-startbutton (for example) and the outer tube is advanced to the distalposition where the hammer crushes the crimp. The tube is held there inplace distally until the cutting assembly is actuated to cut the freeends of the cord/suture at the proximal side of the fixed crimp. Whenthe system indicates that the cutting has completed (e.g., when thecutting stroke is sufficient to insure that cords have been cut), thecutting assembly retracts to its idle position and the outer tube alsoretracts to its idle position, during which the now-crimped first crimpis released from the end effector. Now, the device is in its state forthe next crimping process to begin, which starts with advancing thecrimp conveyor to load the next crimp.

The shape of the crimp shown in FIGS. 32 to 35 is not the only possibleshape for a system that can deliver multiple crimps with a singledelivery device. Another exemplary configuration provides a mechanicalclip 900 that is shown in FIGS. 93 to 101. This clip 900 has a rotatorhousing 910, a rotator cover 920, and a central rotator 930. The rotatorhousing 910 and the rotator cover 920 are fixed together with thecentral rotator 930 rotatably disposed therebetween. The central rotator930 is able to rotate from an open position shown in FIG. 93, through acord-captured position shown in FIG. 94, and then to a cord-securedposition shown in FIGS. 95 and 96. The difference between thecord-captured and the cord-secured positions is that the cord iscaptured in the position of FIG. 94. However, the clip 900 could slidealong the captured cord. By rotating the central rotator 930 further tothe position shown in FIGS. 95 and 96, the cord becomes trapped betweenthe central rotator 930 and the rotator housing 910 within an interface,shown in the exploded view of FIG. 97. This interface is comprised of ahousing lateral surface 912 and an opposing lateral surface 932 of thecentral rotator 930 that is not visible in FIG. 97 but is shown in FIG.98. The lateral surface 932 contains a groove 934 that, in the exemplaryembodiment, starts from a greater depth and ends at a shallow depth.Accordingly, when the central rotator 930 rotates from the cord-capturedposition to the cord-secured position, the cord is forced between thewall of the groove 934 and the housing lateral surface 912 to lock theclip 900 and the cord(s) trapped therein together. FIGS. 100 and 101show the clip 900 in its assembled state with the central rotator 930 inthe open position.

The central rotator 930 also has ratchet grooves 936, two of which areshown in this exemplary embodiment. These ratchet grooves 936 are shapedto mate with a ratchet bar 914 on the rotator housing 910 such that, asthe central rotator 930 rotates (counter-clockwise in FIGS. 93 to 94)from the open position to the cord-captured position, the ratchet groove936 and ratchet bar 914 prevent rotation in the opposite direction,making the clip 900 a one-direction assembly. For a final lockingposition, the mouth 938 of the central rotator 930 has a final lockingsurface 939 that connects with the distal end of the ratchet bar 914 asshown in FIG. 95. In this position, the central rotator 930 is lockedand is crushing the cord(s) within the groove 934.

FIGS. 102 to 109 illustrate how one of a set of multiple clips 900 canbe installed, one-at-a-time, on various cords over a cord-securingprocedure. FIG. 102 shows the clip-delivery system 950 with a clip 900at a distal clip-installation position aligned with a cord raceway 952.In this state, a cord to be secured is guided through the V-shape of theclip 900 in its open position and around the two turns 954, 956 to afinal installed position exiting out from the end of the raceway asindicated by the dashed line. FIG. 103 shows the interior of theclip-delivery system 950 with the exterior shaft transparent. As can beseen here, there are two clips 900 movably installed on clip carriershafts 960. These carrier shafts 960 allow a set of any number of clips900 to be used in a given procedure. FIG. 104 shows that the clip 900has been locked into the cord-captured position by a correspondingrotation of a locking shaft 970. With further rotation of the lockingshaft 970, as shown in FIG. 105, the clip 900 is placed in thecord-secured position. Rotation of the carrier shafts 960 forces theclip 900 off the distal end thereof to remain at the location where itis intended to be secured on the cord(s), thus freeing up the distalinstallation portion of the clip-delivery system 950 for the next clip900, which is adjacent the installation portion in FIG. 107. FIGS. 108and 109 show how the locking shaft 970 is formed at the distal end sothat only the clip in the installation portion of the clip-deliverysystem 950 has its central rotator 930 moved when the locking shaft 970rotates even though many more clips 900 can be located about the lockingshaft 970 proximal of the installation portion.

FIGS. 110 to 125 illustrate various configurations of clips 1000, 1100,1200 that can be loaded with cord(s) from a side thereof instead ofthrough a bore as in the crimp 30. A first exemplary embodiment of aside-loaded clip 1000 illustrated in FIGS. 110 to 116 includes anexternal shell 1010 and an internal rotator lock 1020. The shell 1010has an inwardly extending boss 1012 that rides on a groove 1022 of therotator lock 1020 when the rotator lock 1020 is rotated. FIG. 110illustrates the rotator lock 1020 in an unlocked position where the boss1012 is at the deepest portion of the groove 1022. FIG. 111 illustratesthe rotator lock 1020 in a intermediate partially locked position wherethe boss 1012 is at a shallower portion of the groove 1022. FIG. 112illustrates the rotator lock 1020 in a locked position where the boss1012 is within a lock cavity 1024 just after the shallowest portion ofthe groove 1022. As shown in FIG. 113 the lower portion of the shell1010 has a lower boss 1014 and the lower portion of the rotator lock1020 has a lower groove 1022.

Locking of the clip 1000 to a cord(s) is illustrated with reference toFIGS. 114 to 116. The lower portion of the shell 1010 has cord grooves1014, 1016. In this embodiment, the cord grooves 1014, 1016 are oppositeone another. Similarly, the lower portion of the rotator lock 1020 has acord cavity 1026 that, when aligned with the cord grooves 1014, 1016,form a channel from one side of the shell 1010 to the other. The cordgrooves 1014, 1016 and the cord cavity 1026 are deep enough to allowcords 2 to be inserted therein and, preferably, deep enough to not exitany part of the channel when locked therein. FIG. 114 shows the shell1010 and the rotator lock 1020 in the open/loading position. In thisstate, the cords can be stretched and guided into the channel all theway to the bottom of the channel. Locking of the clip 100 to the cords 2occurs by rotating the rotator lock 1020. FIG. 115 shows the rotatorlock 1020 in an intermediate, partially locked state. FIG. 116 shows therotator lock 1020 in its locked state, which, here, is almost a180-degree rotation. If desired, the outer cylindrical surface of therotator lock 1020, which cannot be seen in these figures, can have acircumferential groove to prevent the cords 2 from exiting the pinchedstate between the interior of the shell 1010 and the exterior of therotator lock 1020. The surfaces between the shell 1010 and the rotatorlock 1020 can be knurled or have other features to increase friction andprevent the cords 2 from exiting the locked clip 1000 without destroyingor unlocking the clip 1000.

FIGS. 117 to 120 illustrate another exemplary embodiment of a laterallyloaded clip 1100 for securing cords 2 therein. The clip 1100 has a mainbody 1110 and an insert 1120. The main body 1110 has a longitudinalchannel 1112 shaped to receive cords 2 therein. At various longitudinaldistances along the channel 1112, the body 1110 has sets of opposingprotrusions 1114 that provide pinching points to hold the cords 2therein. The insert 1120 also has a channel 1122 and sets of opposingprotrusions 1124. The insert 1120 is shaped, as a puzzle piece, to beinserted into the body 1110 between the protrusion sets and lock thecords 2 therebetween in a press fit, as shown in the views of FIGS. 119and 120.

FIGS. 121 to 125 illustrate another exemplary embodiment of a laterallyloaded clip 1200 for securing cords 2 therein. The clip 1200 has atwo-part body 1210, 1220 and a securing ring 1230. The two parts 1210,1220 of the body are connected by a hinge 1212, 1222 that allows the twoparts to open and close like a shell. One body part 1210 has at leastone protrusion 1214 and the other part 1220 has at least onecorresponding groove 1224 into which the protrusion 1214 can rest andcrimp a cord(s) 2 therebetween when the clam-shell of the two parts1210, 1220 are hinged closed. Here, one protrusion and one correspondinggroove is shown but there can be more than one. The protrusion 1212provides a pinching point to hold the cords 2 therein. One of the parts,here the first part 1210, has a groove or channel 1214 shaped to conformat least partly to the cords 2 that are to be clamped between the twoparts 1210, 1220. FIG. 122 shows the two parts 1210, 1220 in acord-loading position. The cords 2, as shown in FIG. 123, are loaded inbetween the parts 1210, 1220 and the parts 1210, 1220 are closed uponthe cords 2. As can be seen in FIGS. 122 and 123, the parts 1210, 1220also provide portions of an exterior circumferential groove 1216, 1226.Together, this circumferential groove 1216, 1226 provides the lockingmechanism for the securing ring 1230. The parts 1210, 1220 have ends atwhich there is a narrowing for receiving the securing ring 1230 thereon.When placed over the narrowing, as shown in FIG. 124, the parts 1210,1220 no longer can separate from one another. To lock the cords 2between the two parts 1210, 1220, as shown in the view of FIG. 125, thesecuring ring 1230 is pressed over the narrowing until the securing ring1230 rests in the groove 1216, 1226. As can be seen by the separationdistance of a split 1232 in the securing ring 1230, the groove 1216,1226 in the locking state is slightly larger than the interiorcircumference of the securing ring 1230. As such, the securing ring 1230provides a strong bias to retain and fix the two parts 1210, 1220together.

One of the primary features of a laterally loaded clip is that such cordloading eliminates the needs to feed the cord(s) through a structure,such as a tube. In the tubular crimp structures, the cord(s) is fedthrough the bore. With a laterally loaded clip, the cord(s) needs onlyto be laid against the side.

When any motors are described herein, they also include, wheredesirable, any gearing or transmissions that are necessary to reduce themotor turns rate to effect the function of that motor. Thesetransmissions are not described herein in further detail.

It is noted that various individual features of the inventive processesand systems may be described only in one exemplary embodiment herein.The particular choice for description herein with regard to a singleexemplary embodiment is not to be taken as a limitation that theparticular feature is only applicable to the embodiment in which it isdescribed. All features described herein are equally applicable to,additive, or interchangeable with any or all of the other exemplaryembodiments described herein and in any combination or grouping orarrangement. In particular, use of a single reference numeral herein toillustrate, define, or describe a particular feature does not mean thatthe feature cannot be associated or equated to another feature inanother drawing figure or description. Further, where two or morereference numerals are used in the figures or in the drawings, thisshould not be construed as being limited to only those embodiments orfeatures, they are equally applicable to similar features or not areference numeral is used or another reference numeral is omitted.

The foregoing description and accompanying drawings illustrate theprinciples, exemplary embodiments, and modes of operation of the devicesand methods. However, the devices and methods should not be construed asbeing limited to the particular embodiments discussed above. Additionalvariations of the embodiments discussed above will be appreciated bythose skilled in the art and the above-described embodiments should beregarded as illustrative rather than restrictive. Accordingly, it shouldbe appreciated that variations to those embodiments can be made by thoseskilled in the art without departing from the scope thereof as definedby the following claims.

What is claimed is:
 1. A multiple-firing clip device, comprising: a plurality of suture fixation clips each having an internal hollow shaped to receive therein at least one suture; a hollow shaft having a distal fixation location, an exterior surface, and an interior; the plurality of the suture fixation clips stacked in the interior, defining a first clip, and configured to move along a longitudinal axis; the shaft defining a lateral opening proximal to the distal fixation location; the lateral opening communicating between the interior and an environment outside the exterior surface; a device movement carriage within the interior of the shaft and configured to deliver the first clip to the distal fixation location by moving the first clip longitudinally from a first proximal position into the distal fixation location; and a shuttle longitudinally movable on the shaft and comprising: a shuttle body; a snare at least partly within the shuttle body, the snare having a distal snare portion; and a snare-movement assembly comprising: a snare-extender slide movably disposed with respect to the shuttle body along a given extent, the given extent defining a slide distance and a distal end; and a snare extender connected to the snare and to the snare-extender slide, the snare extender configured to extend at least the distal snare portion distally to an extent that is at least equal to the slide distance responsive to movement of the snare-extender slide up to the distal end of the given extent and, with that extension, through the distal fixation location.
 2. The device according to claim 1, wherein: the shaft comprises a distal shaft end and a distal shaft portion between the lateral opening and the distal shaft end; and the shuttle is configured to pull a portion of the at least one suture temporarily secured in the snare from distal of the distal shaft end proximally through the internal hollow of the first clip, through the distal shaft portion, and out a side of the shaft through the lateral opening.
 3. The device according to claim 1, wherein: the snare-extender slide comprises a rack fixed thereto and moving correspondingly with the snare-extender slide; the snare has a proximal snare portion and a distal snare end; the snare extender comprises a pinion having a spool and is operatively connected to the rack to rotate as the rack moves with the snare-extender slide; the shaft comprises a distal shaft end and a distal shaft portion between the lateral opening and the distal shaft end; and at least the proximal snare portion is attached to the spool such that, as the spool rotates with the pinion, the distal snare end extends away from the spool through the distal shaft portion, through the distal fixation location, and through the internal hollow of the first clip.
 4. The device according to claim 3, wherein at least the proximal snare portion is wound on the spool such that, as the spool rotates with the pinion, the distal snare end extends away from the spool through the distal shaft portion, through the distal fixation location, through the internal hollow of the first clip, and distal of the distal shaft end.
 5. The device according to claim 1, wherein the snare extender is configured to extend at least the distal snare portion distally to an extent that is longer than the slide distance responsive to movement of the snare-extender slide up to the distal end of the given extent and, with that extension, through the distal fixation location.
 6. The device according to claim 1, wherein: the snare is configured to laterally pass into the interior of the shaft through the lateral opening from the environment, is configured to pass through the internal hollow of the first clip, and is configured to pass out of the interior of the shaft distally past the distal fixation location to temporarily secure a suture portion of the at least one suture within the snare; and the shuttle is configured to pull the suture portion out a side of the shaft through the lateral opening to present at least some of the suture portion out from the lateral opening for access by a user.
 7. The device according to claim 6, wherein: the suture portion temporarily secured in the snare comprises two free ends of a surgical suture; the suture portion being pulled proximally through the first clip comprises the two free ends such that, at a given time, four lengths of the surgical suture are being pulled through the first clip; and the at least some of the suture portion pulled out through the lateral opening for access by a user is the two free ends of the surgical suture.
 8. The device according to claim 1, wherein the internal hollow is one of a lumen and a slot.
 9. The device according to claim 1, wherein the device movement carriage is configured to deliver the first clip to the distal fixation location by moving the first clip longitudinally from the first proximal position into the distal fixation location and returning without the first clip to a second proximal position one of: substantially the same as the second proximal position; and different from the first proximal position.
 10. The device according to claim 9, wherein, responsive to the device movement carriage returning to the second proximal position, the interior is open to the environment through the lateral opening.
 11. The device according to claim 9, wherein, during or after the device movement carriage is in a process of returning to the second proximal position without the first clip, the device movement carriage moves a previously second of the clips into a clip loading position to become a new first clip.
 12. The device according to claim 1, wherein: the first clip has a proximal side; the snare-movement assembly comprises a hollow snare guide having a distal guide portion movable from external of the shaft into the interior through the lateral opening and up to the proximal side of the first clip; the distal snare portion is steady with respect to the snare guide when the distal guide portion is external to the shaft; and the distal snare portion is configured to extend from the snare guide responsive to locating the distal guide portion within the interior.
 13. The device according to claim 1, wherein the shuttle body defines a lumen surrounding the shaft.
 14. The device according to claim 3, wherein the rack has teeth and the pinion is a speed-increasing gear sized to rotate at a gear ratio greater than 1:1 with respect to movement of the rack.
 15. The device according to claim 1, wherein the distal snare portion comprises a loop shaped to extend through the interior of the shaft through the lateral opening from the environment, to pass through the internal hollow of the first clip, and to pass out of the interior of the shaft distally past the distal fixation location.
 16. The device according to claim 15, wherein the loop is substantially ovular.
 17. The device according to claim 1, wherein: the shuttle body has a distal side; the snare-extender slide has a proximal-most, unactuated position and a distal-most, actuated position; the shuttle further comprises a snare-extension tube having a distal tube end adjacent the distal side of the shuttle body; and the snare has a tip and an overall length set to position the tip just outside the distal side of the shuttle body when the snare-extender slide is in the proximal-most, unactuated position.
 18. The device according to claim 17, wherein: the shaft comprises a distal shaft end; and the snare-extension tube is configured to drop at least the distal tube end into the lateral opening of the shaft as the shuttle moves towards the distal shaft end.
 19. A multiple-firing clip device, comprising: a hollow shaft comprising an exterior surface, an interior configured to receive therein a stack of suture fixation clips, and a distal end opening shaped to eject at least one of the suture fixation clips therefrom; the shaft defining a lateral opening communicating between the interior and an environment outside the exterior surface and a distal shaft portion between the lateral opening and the distal end opening; and a shuttle longitudinally movable on the shaft and comprising: a shuttle body defining a lumen surrounding the shaft; a snare connected to the shuttle body and having a distal snare portion; and a snare extension slide: movably disposed with respect to the shuttle body along a given extent, the given extent defining a slide distance and a distal end; and operatively connected to the snare to extend at least the distal snare portion distally along an extent having a length that is at least equal to the slide distance responsive to movement of the snare extension slide up to the distal end of the given extent, and, with that extension, through the lateral opening from the environment into the interior, through the distal shaft portion, and through the distal end opening.
 20. A multiple-firing clip device, comprising: a plurality of suture fixation clips each having an internal hollow shaped to receive therein at least one suture; a hollow shaft having a distal fixation location, an exterior surface, and an interior; the plurality of the suture fixation clips stacked in the interior, defining a first clip, and configured to move along a longitudinal axis; the shaft defining a lateral opening proximal to the distal fixation location; the lateral opening communicating between the interior and an environment outside the exterior surface; a clip movement means within the interior of the shaft to for delivering the first clip to the distal fixation location by moving the first clip longitudinally from a first proximal position into the distal fixation location; and a shuttle longitudinally movable on the shaft and comprising: a shuttle body; a snare at least partly within the shuttle body, the snare having a distal snare portion; and a snare-movement means comprising: a snare-extender slide movably disposed with respect to the shuttle body along a given extent, the given extent defining a slide distance and a distal end; and a snare extender connected to the snare and to the snare-extender slide, the snare extender configured to extend at least the distal snare portion distally to an extent that is at least equal to the slide distance responsive to movement of the snare-extender slide up to the distal end of the given extent and, with that extension, through the distal fixation location. 